Home NDC 71335-1643-0 Baclofen
Product NDC 71335-1643
Requested package NDC 71335-1643-0
11-digit product format 713351643
Labeler code 71335
Product ID 71335-1643_6844d3f9-01ea-428c-bb38-7f13ebf15ec9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211555
Marketing category ANDA
Marketing start 2021-05-27
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 2023-12-31
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 · 15 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211555-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 A211555-002 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2019-02-01 A211555-003 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2021-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 3 · 114 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 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211555-001 BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211555-002 BACLOFEN 20MG TABLET / ORAL AB 2019-02-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211555-003 BACLOFEN 5MG TABLET / ORAL AB 2021-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211555-001 BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1643 BACLOFEN TABLET [BRYANT RANCH PREPACK] 3 Legacy NDC, 10 package rows 20220520_c6a066e5-69e9-4d08-90d9-072840bd438f.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 Marketing end Sample Exclude flag Status 71335-1643-0 71335164300 112 TABLET in 1 BOTTLE (71335-1643-0) 112 tablet 2022-04-29 0000-00-00 No No Current