Home NDC 70752-148 BUTALBITAL and ACETAMINOPHEN
Product NDC 70752-148
11-digit product format 707520148
Labeler code 70752
Product ID 70752-148_d113b27d-2b74-45ad-b095-d0cded8d4f6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUTALBITAL and ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application ANDA214291
Marketing category ANDA
Marketing start 2024-05-01
Substance ACETAMINOPHEN; BUTALBITAL
Active strength 325; 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 42 .
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 A214291-001 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET / ORAL AA 2024-01-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214291-001 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 2026-08-18 06:07:40 2026-07 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214291-001 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2024-01-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BUTALBITAL and ACETAMINOPHEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTALBITAL 325 mg/1 ACETAMINOPHEN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KHS0AZ4JVK Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197426 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 70752-148-10 BUTALBITAL and ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 3 70752-148-14 BUTALBITAL and ACETAMINOPHEN 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70752-148 BUTALBITAL AND ACETAMINOPHEN TABLET [QUAGEN PHARMACEUTICALS LLC] 3 Current NDC, 2 package rows 20240508_2eb09253-7f59-401e-afbc-70bb9600fedf.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 70752-148-10 70752014810 100 TABLET in 1 BOTTLE (70752-148-10) 100 tablet 2024-05-01 No No Current 70752-148-14 70752014814 500 TABLET in 1 BOTTLE (70752-148-14) 500 tablet 2024-05-01 No No Current