Home NDC 55289-757 Baclofen
Product NDC 55289-757
11-digit product format 552890757
Labeler code 55289
Product ID 55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA072234
Marketing category ANDA
Marketing start 1988-07-21
Substance BACLOFEN
Active strength 10 mg/1
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 A072234-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 1988-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072234-001 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.
Product history page 1 of 2 · 41 observed 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 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 10 mg/1
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 197391 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 55289-757-30 Baclofen 30 in 1 BOTTLE, PLASTIC TABLET 30 27 55289-757-60 Baclofen 60 in 1 BOTTLE, PLASTIC TABLET 60 27 55289-757-90 Baclofen 90 in 1 BOTTLE, PLASTIC TABLET 90 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Baclofen ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 Baclofen ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-757 BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] 26 Current NDC, Legacy NDC, 3 package rows 20241012_95755a7b-4a9f-45ea-a381-d3f661150efe.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baclofen BACLOFEN Northwind Health Company, LLC 06bcfb08-2ada-f803-e063-6394a90a826b 2025-12-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN PD-Rx Pharmaceuticals, Inc. 95755a7b-4a9f-45ea-a381-d3f661150efe 2025-10-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 55289-757 Baclofen BACLOFEN Advanced Rx of Tennessee, LLC b33c4164-e607-2e27-e053-2a95a90ad7db 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN Proficient Rx LP b981eb16-a195-41da-a186-3e91b63b2def 2024-10-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN Teva Pharmaceuticals USA, Inc. 5648c772-50cb-4961-996e-e68a8eb699ea 2019-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-757-30 55289075730 30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30) 30 tablet 2009-03-24 0000-00-00 No No Current 55289-757-60 55289075760 60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60) 60 tablet 2009-03-24 0000-00-00 No No Current 55289-757-90 55289075790 90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90) 90 tablet 2007-12-26 0000-00-00 No No Current