Consumer Product Safety Improvement Act of 2008 (CPSIA)
The following is a list of prescription products that are distributed by Cephalon Inc. and which are subject to the provisions of the CPSIA, in accordance with the requirements for assuring that each product complies with the special packaging requirements of the Poison Prevention Packaging Act (PPPA) of 1970, as amended. The testing is conducted in accordance with the Consumer Product Safety Commission’s (CPSC) current protocol and standards as per the Code of Federal Regulations (CFR) Title 16, Part 1700.
| NDC # | Product Description | Package Testing Company | Report # / Date | Commercial Packaging Site(s) |
|---|---|---|---|---|
| 63459-502-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 200mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-504-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 400mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-506-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 600mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-508-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 800mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-512-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 1200mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-516-30 | ACTIQ (Oral Transmucosal Fentanyl Citrate) 1600mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-700-60 | AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) 15mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-009 Nov. 2, 2001 |
Legacy Pharmaceuticals Switzerland GmbH Rührbergstrasse 21 CH-4127 Birsfelden Switzerland Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-701-60 | AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) 30mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-009 Nov. 2, 2001 |
Legacy Pharmaceuticals Switzerland GmbH Rührbergstrasse 21 CH-4127 Birsfelden Switzerland Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
55253-276-60 |
Cyclobenzaprine Hydrochloride Extended-Release Capsules 15mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-009 Nov. 2, 2001 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
55253-277-60 |
Cyclobenzaprine Hydrochloride Extended-Release Capsules 30mg, 60-count bottle |
Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-009 Nov. 2, 2001 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-541-28 | FENTORA (Fentanyl Buccal Tablet) 100mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6026 June 28, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-542-28 | FENTORA (Fentanyl Buccal Tablet) 200mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6018 May 17, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-543-28 | FENTORA (Fentanyl Buccal Tablet) 300mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6018 May 17, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-544-28 | FENTORA (Fentanyl Buccal Tablet) 400mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6018 May 17, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-546-28 | FENTORA (Fentanyl Buccal Tablet) 600mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6018 May 17, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-548-28 | FENTORA (Fentanyl Buccal Tablet) 800mcg 28 Count | Forensic Packaging Concepts 140 West Hills Court Harriman, TN 37748 |
K6018 May 17, 2006 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-402-30 | GABITRIL (Tiagabine Hydrochloride Tablets) 2mg, 30-count bottle | Great Lakes Marketing 3103 Executive Parkway Toledo, OH 43606 |
GLM22008Ch January 2004 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-404-30 | GABITRIL (Tiagabine Hydrochloride Tablets) 4mg, 30-count bottle | Great Lakes Marketing 3103 Executive Parkway Toledo, OH 43606 |
GLM22008Ch January 2004 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-412-30 | GABITRIL (Tiagabine Hydrochloride Tablets) 12mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-416-30 | GABITRIL (Tiagabine Hydrochloride Tablets) 16mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-205-30 | NUVIGIL (Armodafinil Tablets) 50mg, 30-count bottle | Great Lakes Marketing 3103 Executive Parkway Toledo, OH 43606 |
GLM22008Ch January 2004 | Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-205-60 | NUVIGIL (Armodafinil Tablets) 50mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-009 Nov. 2, 2001 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-215-30 | NUVIGIL (Armodafinil Tablets) 150mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-215-60 | NUVIGIL (Armodafinil Tablets) 150mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-225-30 | NUVIGIL (Armodafinil Tablets) 250mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-225-60 | NUVIGIL (Armodafinil Tablets) 250mg, 60-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 55253-070-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 200mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 55253-071-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 400mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 55253-072-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 600mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 55253-073-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 800mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 55253-074-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 1200mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 55253-075-30 | Oral Transmucosal Fentanyl Citrate (OTFC) 1600mcg 30 Count | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1435-006 April 18, 2002 |
Anesta Corp. 4745 Wiley Post Way Salt Lake City, UT 84116 |
| 63459-101-30 | PROVIGIL (Modafinil Tablets) 100mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-101-01 | PROVIGIL (Modafinil Tablets) 100mg, 100-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-201-30 | PROVIGIL (Modafinil Tablets) 200mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 63459-201-01 | PROVIGIL (Modafinil Tablets) 200mg, 100-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 55253-801-30 | Modafinil AG Tablets 100 mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 55253-802-30 |
Modafinil AG Tablets 200 mg, 30-count bottle |
Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 55253-801-90 |
Modafinil AG Tablets 100 mg, 90-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
1392-007 Jan. 31, 2000 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |
| 55253-802-90 | Modafinil AG Tablets 200 mg, 30-count bottle | Perritt Laboratories 145 South Main Street Hightstown, NJ 08520 |
TEV09-15 Nov. 6, 2009 |
Sharp Corporation 7451 Keebler Way Allentown, PA 18106 |