Home NDC 50436-9022-1 Baclofen
Product NDC 50436-9022
Requested package NDC 50436-9022-1
11-digit product format 504369022
Labeler code 50436
Product ID 50436-9022_09d2deae-1b90-4d32-8d8e-390a5e193d18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Unit Dose Services
Application ANDA072234
Marketing category ANDA
Marketing start 1988-07-21
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-9022-1 Baclofen 30 in 1 BOTTLE TABLET 30 6 50436-9022-2 Baclofen 60 in 1 BOTTLE TABLET 60 6 50436-9022-3 Baclofen 90 in 1 BOTTLE TABLET 90 6 50436-9022-5 Baclofen 120 in 1 BOTTLE TABLET 120 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-9022 BACLOFEN TABLET [UNIT DOSE SERVICES] 6 Legacy NDC, 4 package rows 20210325_ec9c8b7f-9fb0-4274-9532-2fee335c055d.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 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 50436-9022-1 50436902201 30 TABLET in 1 BOTTLE (50436-9022-1) 30 tablet 2021-03-24 0000-00-00 No No Current