Home NDC 0781-3250 Glatopa
Product NDC 0781-3250
11-digit product format 007813250
Labeler code 0781
Product ID 0781-3250_ccec47d1-47be-4953-a7fe-ad66c9186962
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glatiramer Acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Sandoz Inc
Application ANDA206921
Marketing category ANDA
Marketing start 2018-02-12
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 A206921-001 GLATOPA GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206921-001 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 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206921-001 GLATOPA 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2018-02-12 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 Glatopa
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111641 Internal RxNorm lookup 1487361 Internal RxNorm lookup 1654630 Internal RxNorm lookup 2000007 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 0781-3250-71 Glatopa 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 28 0781-3250-89 Glatopa 12 in 1 CARTON INJECTION, SOLUTION 12 28 0781-3250-89 Glatopa 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3250 GLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [SANDOZ INC] 28 Current NDC, Legacy NDC, 3 package rows 20250214_5f01e40a-b6f6-40fb-b37c-3d06f1428e86.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 · 2 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 0781-3250-71 00781325071 1 mL in 1 SYRINGE, GLASS 1 ml Historical 0781-3250-89 00781325089 12 BLISTER PACK in 1 CARTON (0781-3250-89) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71) 12 blister pack 2018-02-12 0000-00-00 No No Current