Home NDC 82983-430 Glatiramer Acetate
Product NDC 82983-430
11-digit product format 829830430
Labeler code 82983
Product ID 82983-430_596fb2ff-60b9-46f0-b5c7-00e3108e8f28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glatiramer acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler AJENAT PHARMACEUTICALS LLC
Application ANDA214022
Marketing category ANDA
Marketing start 2026-03-20
Substance GLATIRAMER ACETATE
Active strength 40 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 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 A214022-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 40MG/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 A214022-001 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 2026-08-18 06:07:40 2026-07 A214022-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214022-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214022-001 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2026-02-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A214022-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214022-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214022-001 AP 1 a50c72e98297…
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 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 82983-430-01 Glatiramer Acetate 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 2 82983-430-01 Glatiramer Acetate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 2 82983-430-12 Glatiramer Acetate 12 in 1 CARTON INJECTION, SOLUTION 12 2
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 Sample Exclude flag Status 82983-430-01 82983043001 1 mL in 1 SYRINGE 1 ml Historical 82983-430-12 82983043012 12 BLISTER PACK in 1 CARTON (82983-430-12) / 1 SYRINGE in 1 BLISTER PACK (82983-430-01) / 1 mL in 1 SYRINGE 12 blister pack 2026-03-20 No No Current