Home NDC 81005-123-01 BUTALBITAL AND ACETAMINOPHEN
Product NDC 81005-123
Requested package NDC 81005-123-01
11-digit product format 810050123
Labeler code 81005
Product ID 81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital and acetaminophen
Dosage form TABLET
Route ORAL
Labeler Aarkish Pharmaceuticals NJ Inc.
Application ANDA214955
Marketing category ANDA
Marketing start 2024-12-03
Substance ACETAMINOPHEN; BUTALBITAL
Active strength 300; 50 mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 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 2026-09-14 22:38:34 2026-08 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BUTALBITAL AND ACETAMINOPHEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 300 mg/1 BUTALBITAL 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup KHS0AZ4JVK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1249617 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 81005-123-01 BUTALBITAL AND ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81005-123 BUTALBITAL AND ACETAMINOPHEN TABLET [AARKISH PHARMACEUTICALS NJ INC.] 5 Current NDC, 1 package rows 20241206_82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81005-123-01 81005012301 100 TABLET in 1 BOTTLE (81005-123-01) 100 tablet 2024-12-03 No No Current