Home NDC 62559-204 Baclofen
Product NDC 62559-204
11-digit product format 625590204
Labeler code 62559
Product ID 62559-204_1c95cf7d-6db8-437d-9e33-f8ecb151eca6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA217252
Marketing category ANDA
Marketing start 2024-03-18
Substance BACLOFEN
Active strength 5 mg/mL
Pharmacologic classes GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
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 1 .
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 A217252-001 BACLOFEN BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217252-001 AB
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 2026-02-19 14:30 UTC 2026-02 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217252-001 BACLOFEN 25MG/5ML SUSPENSION / ORAL AB 2023-06-08 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A217252-001 PC 2023-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217252-001 PC 2023-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217252-001 PC 2023-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217252-001 PC 2023-12-16 a67488948f0b…
Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H789N3FKE8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2593376 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 62559-204-03 Baclofen 300 mL in 1 BOTTLE SUSPENSION 300 2 62559-204-03 Baclofen 1 in 1 CARTON SUSPENSION 1 2 62559-204-12 Baclofen 120 mL in 1 BOTTLE SUSPENSION 120 2 62559-204-12 Baclofen 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-204 BACLOFEN SUSPENSION [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 4 package rows 20240323_c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0.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 Sample Exclude flag Status 62559-204-03 62559020403 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLE 1 bottle 2024-03-19 No No Current 62559-204-12 62559020412 1 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLE 1 bottle 2024-03-18 No No Current