Home NDC 61919-027 BACLOFEN
Product NDC 61919-027
11-digit product format 619190027
Labeler code 61919
Product ID 61919-027_9c5970fb-9bc3-6e87-e053-2a95a90a6889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BACLOFEN
Dosage form TABLET
Route ORAL
Labeler Direct Rx
Application ANDA072235
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance BACLOFEN
Active strength 20 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 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 61919-027 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61919-027 61919-027-90 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A072235-001 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB RS 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 A072235-001 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 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61919-027-90 61919002790 90 BOTTLE in 1 BOTTLE (61919-027-90) > 60 BOTTLE in 1 BOTTLE (61919-027-60) > 30 TABLET in 1 BOTTLE (61919-027-30) 90 bottle 2015-01-01 0000-00-00 No No Current