Home NDC 0095-3000-01 BUPAP
Product NDC 0095-3000
Requested package NDC 0095-3000-01
11-digit product format 000953000
Labeler code 0095
Product ID 0095-3000_16609ec3-578a-4f92-83d4-85d58e23cd8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital and Acetaminophen Tablets
Dosage form TABLET
Route ORAL
Labeler Bausch Health US, LLC
Application ANDA090956
Marketing category ANDA
Marketing start 2013-06-24
Marketing end 0000-00-00
Substance BUTALBITAL; ACETAMINOPHEN
Active strength 50 mg/1; mg/1
Pharmacologic classes Barbiturates [CS],Barbiturate [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 6 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090956-001 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 300MG;50MG TABLET / ORAL AA RS 2011-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090956-001 AA
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 · 43 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 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090956-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA RS 2011-08-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
DailyMed Socrata Ingredients# 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 · 1 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 0095-3000-01 00095300001 100 TABLET in 1 BOTTLE, PLASTIC (0095-3000-01) 100 tablet 2013-06-24 0000-00-00 No No Current