Home NDC 47335-990 Glatiramer Acetate
Product NDC 47335-990
11-digit product format 473350990
Labeler code 47335
Product ID 47335-990_3b31bc9a-3536-4485-ae0d-05acf7c2787d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glatiramer Acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA203857
Marketing category ANDA
Marketing start 2025-08-15
Substance GLATIRAMER ACETATE
Active strength 20 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 A203857-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203857-001 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 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203857-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2024-09-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111641 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 47335-990-02 Glatiramer Acetate 30 in 1 CARTON INJECTION, SOLUTION 30 8 47335-990-02 Glatiramer Acetate 1 in 1 BLISTER PACK 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 47335-990-02 47335099002 30 BLISTER PACK in 1 CARTON (47335-990-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE 30 blister pack 2025-08-15 No No Current