Home NDC 0378-6961 Glatiramer Acetate
Product NDC 0378-6961
11-digit product format 003786961
Labeler code 0378
Product ID 0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glatiramer
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Mylan Pharmaceuticals Inc.
Application ANDA206936
Marketing category ANDA
Marketing start 2017-10-04
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206936-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206936-001 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 2 · 42 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 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206936-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2017-10-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Glatiramer Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLATIRAMER ACETATE 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1487361 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-6961-12 Glatiramer Acetate 12 in 1 CARTON INJECTION, SOLUTION 12 14 0378-6961-32 Glatiramer Acetate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 14 0378-6961-32 Glatiramer Acetate 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6961 GLATIRAMER ACETATE (GLATIRAMER) INJECTION, SOLUTION [MYLAN PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 3 package rows 20250515_456a34c7-8511-4000-99a7-ad8f8de6d35e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-6961-12 00378696112 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE 12 blister pack 2017-10-04 0000-00-00 No No Current 0378-6961-32 00378696132 1 in 1 BLISTER PACK Historical