Home NDC 82983-429 Glatiramer Acetate
Product NDC 82983-429
11-digit product format 829830429
Labeler code 82983
Product ID 82983-429_bd2ebc53-149c-420d-8986-3fe3c3aeec82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glatiramer acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler AJENAT PHARMACEUTICALS LLC
Application ANDA213382
Marketing category ANDA
Marketing start 2026-03-20
Substance GLATIRAMER ACETATE
Active strength 20 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213382-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213382-001 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.
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 2026-09-14 22:38:34 2026-08 A213382-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213382-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213382-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213382-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glatiramer Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLATIRAMER ACETATE 20 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82983-429-01 Glatiramer Acetate 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 2 82983-429-01 Glatiramer Acetate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 2 82983-429-30 Glatiramer Acetate 30 in 1 CARTON INJECTION, SOLUTION 30 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82983-429-01 82983042901 1 mL in 1 SYRINGE 1 ml Historical 82983-429-30 82983042930 30 BLISTER PACK in 1 CARTON (82983-429-30) / 1 SYRINGE in 1 BLISTER PACK (82983-429-01) / 1 mL in 1 SYRINGE 30 blister pack 2026-03-20 No No Current