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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020622-001COPAXONEGLATIRAMER ACETATE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20
N020622-002COPAXONEGLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12
N020622-003COPAXONEGLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020622-002AP
N020622-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020622-002COPAXONE20MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2002-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020622-003COPAXONE40MG/MLINJECTABLE / SUBCUTANEOUSAPRLD, RS2014-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020622-001COPAXONE20MG/VIALFOR SOLUTION / SUBCUTANEOUSRLD1996-12-201e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020622-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020622-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020622-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020622-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020622-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020622-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020622-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020622-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020622-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020622-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020622-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020622-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020622-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020622-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020622-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020622-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020622-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020622-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020622-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020622-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020622-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020622-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020622-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020622-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020622-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020622-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020622-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020622-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020622-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020622-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020622-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020622-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020622-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020622-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020622-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020622-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020622-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020622-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020622-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020622-003AP1bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020622-00382322502030-08-19U-4412014-02-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020622-00383994132030-08-19U-4412014-02-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020622-00389693022030-08-19U-4412015-03-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020622-00391557762030-08-19U-4412015-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020622-00394028742030-08-19U-4412016-08-0274a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020622-00382322502030-08-19U-4412014-02-263f01610625f2…
2019-12-14 00:12 UTC2019-12N020622-00383994132030-08-19U-4412014-02-263f01610625f2…
2019-12-14 00:12 UTC2019-12N020622-00389693022030-08-19U-4412015-03-033f01610625f2…
2019-12-14 00:12 UTC2019-12N020622-00391557762030-08-19U-4412015-10-133f01610625f2…
2019-12-14 00:12 UTC2019-12N020622-00394028742030-08-19U-4412016-08-023f01610625f2…
2019-09-15 20:21 UTC2019-09N020622-00382322502030-08-19U-4412014-02-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N020622-00383994132030-08-19U-4412014-02-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N020622-00389693022030-08-19U-4412015-03-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N020622-00391557762030-08-19U-4412015-10-13b00525d2431f…
2019-09-15 20:21 UTC2019-09N020622-00394028742030-08-19U-4412016-08-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N020622-00382322502030-08-19U-4412014-02-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N020622-00383994132030-08-19U-4412014-02-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N020622-00389693022030-08-19U-4412015-03-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N020622-00391557762030-08-19U-4412015-10-13ea99ee380514…
2019-07-19 19:46 UTC2019-07N020622-00394028742030-08-19U-4412016-08-02ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Copaxone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLATIRAMER ACETATE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5M691HL4BOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa88f583-4f5f-433b-80b4-1f4c9fb28357Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68546-325-06Copaxone6 in 1 CARTONINJECTION, SOLUTION635
68546-325-06Copaxone1 in 1 BLISTER PACKINJECTION, SOLUTION135
68546-325-12Copaxone12 in 1 CARTONINJECTION, SOLUTION1235
68546-325-12Copaxone1 in 1 BLISTER PACKINJECTION, SOLUTION135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68546-325-06ML - Milliliter68546-32541ee89e1-f1f6-4790-b387-713218c05d1b12016-05-16
68546-325-12ML - Milliliter68546-32528a02926-81cd-450c-93a4-9a32689b08e912014-02-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-325COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.]35Current NDC, Legacy NDC, 4 package rows20250221_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CopaxoneGLATIRAMER ACETATETeva Neuroscience, Inc.aa88f583-4f5f-433b-80b4-1f4c9fb283572026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020622
application number: NDA020622
ndc (product): 68546-325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111642Copaxone 20 MG in 1 mL Prefilled SyringePSNaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1487363Copaxone 40 MG in 1 ML Prefilled SyringePSNaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1111641glatiramer acetate 20 MG in 1 ML Prefilled SyringePSNaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1487361glatiramer acetate 40 MG/ML in 1 ML Prefilled SyringePSNaa88f583-4f5f-433b-80b4-1f4c9fb2835735
11116421 ML glatiramer acetate 20 MG/ML Prefilled Syringe [Copaxone]SBDaa88f583-4f5f-433b-80b4-1f4c9fb2835735
14873631 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone]SBDaa88f583-4f5f-433b-80b4-1f4c9fb2835735
11116411 ML glatiramer acetate 20 MG/ML Prefilled SyringeSCDaa88f583-4f5f-433b-80b4-1f4c9fb2835735
14873611 ML glatiramer acetate 40 MG/ML Prefilled SyringeSCDaa88f583-4f5f-433b-80b4-1f4c9fb2835735
11116421 ML Copaxone 20 MG/ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735
14873631 ML Copaxone 40 MG/ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1111642Copaxone 20 MG per 1 ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1487363Copaxone 40 MG/ML 1 ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1111641glatiramer acetate 20 MG per 1 ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735
1487361glatiramer acetate 40 MG/ML per 1 ML Prefilled SyringeSYaa88f583-4f5f-433b-80b4-1f4c9fb2835735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68546-325-06685460325066 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS6 blister pack2014-01-290000-00-00NoNoCurrent
68546-325-126854603251212 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS12 blister pack2014-01-290000-00-00NoNoCurrent