Home NDC 0832-6084 Glatiramer Acetate
Product NDC 0832-6084
11-digit product format 008326084
Labeler code 0832
Product ID 0832-6084_991aa361-3f99-42cd-948b-5b1271b346c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glatiramer Acetate Injection
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler UPSHER-SMITH LABORATORIES, LLC
Application ANDA214741
Marketing category ANDA
Marketing start 2026-01-23
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214741-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 A214741-002 GLATIRAMER ACETATE GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214741-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214741-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-12-31 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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111641 Internal RxNorm lookup 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 0832-6084-30 Glatiramer Acetate 30 in 1 CARTON INJECTION, SOLUTION 30 8 0832-6084-89 Glatiramer Acetate 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 8
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 0832-6084-30 00832608430 30 SYRINGE, GLASS in 1 CARTON (0832-6084-30) / 1 mL in 1 SYRINGE, GLASS (0832-6084-89) 2026-01-23 No No Current 0832-6084-89 00832608489 1 mL in 1 SYRINGE, GLASS 1 ml Historical