Home NDC 71335-2767 Baclofen
Product NDC 71335-2767
11-digit product format 713352767
Labeler code 71335
Product ID 71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA212378
Marketing category ANDA
Marketing start 2024-06-15
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 44 .
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 A212378-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 A212378-002 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 A212378-003 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2021-04-30
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 2026-10-15 13:18:30 2026-09 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# 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 2 of 2 · 23 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 71335-2767-0 71335276700 112 TABLET in 1 BLISTER PACK (71335-2767-0) 112 tablet 2025-10-03 No No Current 71335-2767-1 71335276701 30 TABLET in 1 BLISTER PACK (71335-2767-1) 30 tablet 2025-10-03 No No Current 71335-2767-2 71335276702 120 TABLET in 1 BLISTER PACK (71335-2767-2) 120 tablet 2025-10-03 No No Current 71335-2767-3 71335276703 20 TABLET in 1 BLISTER PACK (71335-2767-3) 20 tablet 2025-10-03 No No Current 71335-2767-4 71335276704 60 TABLET in 1 BLISTER PACK (71335-2767-4) 60 tablet 2025-10-03 No No Current 71335-2767-5 71335276705 100 TABLET in 1 BLISTER PACK (71335-2767-5) 100 tablet 2025-10-03 No No Current 71335-2767-6 71335276706 56 TABLET in 1 BLISTER PACK (71335-2767-6) 56 tablet 2025-10-03 No No Current 71335-2767-7 71335276707 90 TABLET in 1 BLISTER PACK (71335-2767-7) 90 tablet 2025-10-03 No No Current 71335-2767-8 71335276708 140 TABLET in 1 BLISTER PACK (71335-2767-8) 140 tablet 2025-10-03 No No Current 71335-2767-9 71335276709 84 TABLET in 1 BLISTER PACK (71335-2767-9) 84 tablet 2025-10-03 No No Current