Home NDC 71406-109-05 BUTALBITAL AND ACETAMINOPHEN
Product NDC 71406-109
Requested package NDC 71406-109-05
11-digit product format 714060109
Labeler code 71406
Product ID 71406-109_f0d2490a-138b-34b8-e053-2a95a90a2fc7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital and acetaminophen
Dosage form TABLET
Route ORAL
Labeler AACE Pharmaceuticals, Inc.
Application ANDA214955
Marketing category ANDA
Marketing start 2021-10-07
Marketing end 0000-00-00
Substance ACETAMINOPHEN; BUTALBITAL
Active strength 300 mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS]
DEA schedule CIII
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 · 12 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…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A214955-001 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 300MG;50MG TABLET / ORAL AA 2022-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214955-001 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.
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 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 71406-109-05 71406010905 500 TABLET in 1 BOTTLE (71406-109-05) 500 tablet 2021-10-07 0000-00-00 No No Current