Copaxone
- Product NDC
- 68546-325
- 11-digit product format
- 685460325
- Labeler code
- 68546
- Product ID
- 68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glatiramer Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Teva Neuroscience, Inc.
- Application
- NDA020622
- Marketing category
- NDA
- Marketing start
- 2014-01-29
- Substance
- GLATIRAMER ACETATE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020622-001 | COPAXONE | GLATIRAMER ACETATE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | |
| N020622-002 | COPAXONE | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 |
| N020622-003 | COPAXONE | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020622-002 | AP |
| N020622-003 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020622-002 | COPAXONE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2002-02-12 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020622-003 | COPAXONE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2014-01-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020622-001 | COPAXONE | 20MG/VIAL | FOR SOLUTION / SUBCUTANEOUS | RLD | 1996-12-20 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020622-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020622-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020622-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020622-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020622-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020622-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020622-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020622-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020622-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020622-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020622-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020622-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020622-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020622-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020622-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020622-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020622-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020622-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020622-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020622-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020622-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020622-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020622-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020622-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020622-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020622-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020622-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020622-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020622-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020622-003 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020622-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020622-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020622-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020622-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020622-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020622-003 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020622-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020622-003 | AP | 1 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | 8232250 | 2030-08-19 | U-441 | 2014-02-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | 8399413 | 2030-08-19 | U-441 | 2014-02-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | 8969302 | 2030-08-19 | U-441 | 2015-03-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | 9155776 | 2030-08-19 | U-441 | 2015-10-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020622-003 | 9402874 | 2030-08-19 | U-441 | 2016-08-02 | 74a2ff9319b5… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020622-003 | 8232250 | 2030-08-19 | U-441 | 2014-02-26 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020622-003 | 8399413 | 2030-08-19 | U-441 | 2014-02-26 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020622-003 | 8969302 | 2030-08-19 | U-441 | 2015-03-03 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020622-003 | 9155776 | 2030-08-19 | U-441 | 2015-10-13 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020622-003 | 9402874 | 2030-08-19 | U-441 | 2016-08-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020622-003 | 8232250 | 2030-08-19 | U-441 | 2014-02-26 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020622-003 | 8399413 | 2030-08-19 | U-441 | 2014-02-26 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020622-003 | 8969302 | 2030-08-19 | U-441 | 2015-03-03 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020622-003 | 9155776 | 2030-08-19 | U-441 | 2015-10-13 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020622-003 | 9402874 | 2030-08-19 | U-441 | 2016-08-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020622-003 | 8232250 | 2030-08-19 | U-441 | 2014-02-26 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020622-003 | 8399413 | 2030-08-19 | U-441 | 2014-02-26 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020622-003 | 8969302 | 2030-08-19 | U-441 | 2015-03-03 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020622-003 | 9155776 | 2030-08-19 | U-441 | 2015-10-13 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020622-003 | 9402874 | 2030-08-19 | U-441 | 2016-08-02 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Copaxone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLATIRAMER ACETATE | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5M691HL4BO | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aa88f583-4f5f-433b-80b4-1f4c9fb28357 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a4ee46d8-7228-4160-88ad-868cc5abf72f | Product name | 5 | 20260223 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68546-325-06 | Copaxone | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | 35 | |
| 68546-325-06 | Copaxone | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | 35 | |
| 68546-325-12 | Copaxone | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | 35 | |
| 68546-325-12 | Copaxone | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | 35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68546-325-06 | ML - Milliliter | 68546-325 | 41ee89e1-f1f6-4790-b387-713218c05d1b | 1 | 2016-05-16 |
| 68546-325-12 | ML - Milliliter | 68546-325 | 28a02926-81cd-450c-93a4-9a32689b08e9 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLATIRAMER ACETATE | ACTIVE INGREDIENT | 5M691HL4BO | COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.] | 9 | |
| GLATIRAMER | ACTIVE MOIETY | U782C039QP | COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.] | 9 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.] | 9 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Copaxone | GLATIRAMER ACETATE | Teva Neuroscience, Inc. | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 020622 NDA020622 68546-325 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111642 | Copaxone 20 MG in 1 mL Prefilled Syringe | PSN | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487363 | Copaxone 40 MG in 1 ML Prefilled Syringe | PSN | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111641 | glatiramer acetate 20 MG in 1 ML Prefilled Syringe | PSN | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487361 | glatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe | PSN | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111642 | 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [Copaxone] | SBD | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487363 | 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone] | SBD | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111641 | 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe | SCD | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487361 | 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe | SCD | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111642 | 1 ML Copaxone 20 MG/ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487363 | 1 ML Copaxone 40 MG/ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111642 | Copaxone 20 MG per 1 ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487363 | Copaxone 40 MG/ML 1 ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1111641 | glatiramer acetate 20 MG per 1 ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
| 1487361 | glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe | SY | aa88f583-4f5f-433b-80b4-1f4c9fb28357 | 35 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68546-325-06 | 68546032506 | 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 6 blister pack | 2014-01-29 | 0000-00-00 | No | No | Current |
| 68546-325-12 | 68546032512 | 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 12 blister pack | 2014-01-29 | 0000-00-00 | No | No | Current |