Home NDC 68071-2414 Baclofen
Product NDC 68071-2414
11-digit product format 680712414
Labeler code 68071
Product ID 68071-2414_e6607b0c-7d83-22cb-e053-2995a90acc76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA212378
Marketing category ANDA
Marketing start 2020-10-09
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-2414-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-2414-4 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-2414-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-2414-4 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-2414-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-2414-4 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-2414-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-2414-4 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-2414-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-2414-4 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-2414-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-2414-4 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2414-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2414-4 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2414-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2414-4 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2414-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2414-4 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 111 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 68071-2414-3 Baclofen 30 in 1 BOTTLE TABLET 30 2 68071-2414-4 Baclofen 40 in 1 BOTTLE TABLET 40 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2414 BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Legacy NDC, 2 package rows 20220818_c31518c9-b3b5-acc7-e053-2995a90a27d9.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 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 Marketing end Sample Exclude flag Status 68071-2414-3 68071241403 30 TABLET in 1 BOTTLE (68071-2414-3) 30 tablet 2021-05-24 0000-00-00 No No Current 68071-2414-4 68071241404 40 TABLET in 1 BOTTLE (68071-2414-4) 40 tablet 2021-05-24 0000-00-00 No No Current