Copaxone

Product NDC: 68546-317
11-digit product format: 685460317
Labeler code: 68546
Product ID: 68546-317_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: 2008-04-28
Substance: GLATIRAMER ACETATE
Active strength: 20 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68546-317	68546-317-00	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
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#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
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 table
Captured	Edition	Application-product	Patent	Expiration	Use code	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 table
Ingredient	Strength
GLATIRAMER ACETATE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5M691HL4BO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1111641	Internal RxNorm lookup
1111642	Internal RxNorm lookup
1487361	Internal RxNorm lookup
1487363	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa88f583-4f5f-433b-80b4-1f4c9fb28357	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a4ee46d8-7228-4160-88ad-868cc5abf72f	Product name	5	20260223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68546-317-00	Copaxone	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	35
68546-317-00	Copaxone	14 in 1 CARTON	INJECTION, SOLUTION	14	35
68546-317-30	Copaxone	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	35
68546-317-30	Copaxone	30 in 1 CARTON	INJECTION, SOLUTION	30	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68546-317-30	ML - Milliliter	68546-317	24920de1-9855-45a1-bbdf-3789856fa7e9	2	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68546-317	COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.]	35	Current NDC, Legacy NDC, 4 package rows	20250221_aa88f583-4f5f-433b-80b4-1f4c9fb28357.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 020622 application number: NDA020622 ndc (product): 68546-317

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5M691HL4BO	GLATIRAMER ACETATE	147245-92-9	GLATIRAMER ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68546-317-00	68546031700	1 in 1 BLISTER PACK						Historical
68546-317-30	68546031730	30 BLISTER PACK in 1 CARTON (68546-317-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS	30 blister pack	2008-04-28	0000-00-00	No	No	Current