Home NDC 16714-071 Baclofen
Product NDC 16714-071
11-digit product format 167140071
Labeler code 16714
Product ID 16714-071_a3881489-a033-4a93-ba24-590e316103f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Northstar RxLLC
Application ANDA078401
Marketing category ANDA
Marketing start 2011-01-01
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078401-001 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 A078401-002 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2009-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 82 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 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078401-001 BACLOFEN 20MG TABLET / ORAL AB 2009-09-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078401-002 BACLOFEN 10MG TABLET / ORAL AB 2009-09-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197391 Internal RxNorm lookup 197392 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 16714-071-04 Baclofen 100 in 1 BOTTLE TABLET 100 17 16714-071-06 Baclofen 1000 in 1 BOTTLE TABLET 1000 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-071 BACLOFEN TABLET [NORTHSTAR RXLLC] 16 Current NDC, Legacy NDC, 2 package rows 20250409_0aac77fa-30c2-46c8-a04d-e6b8333ddd81.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 · 4 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 16714-071-04 16714007104 100 TABLET in 1 BOTTLE (16714-071-04) 100 tablet 2011-01-01 0000-00-00 No No Current 16714-071-06 16714007106 1000 TABLET in 1 BOTTLE (16714-071-06) 1000 tablet 2011-01-01 0000-00-00 No No Current