Home NDC 70752-141 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 70752-141
11-digit product format 707520141
Labeler code 70752
Product ID 70752-141_be5ec0f7-35dc-4a88-af15-45c70c44be08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form CAPSULE
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application ANDA216376
Marketing category ANDA
Marketing start 2022-08-06
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [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 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216376-001 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 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216376-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA 2024-03-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTALBITAL 325 mg/1 ACETAMINOPHEN 50 mg/1 CAFFEINE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KHS0AZ4JVK Internal UNII lookup 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238153 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 70752-141-10 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE, PLASTIC CAPSULE 100 2 70752-141-14 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 500 in 1 BOTTLE, PLASTIC CAPSULE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70752-141 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [QUAGEN PHARMACEUTICALS LLC] 2 Current NDC, 2 package rows 20250121_5f3c7457-6670-4a0d-bdff-c3e0fe91b7c6.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Bryant Ranch Prepack 8a4cf981-37f7-4bc9-a9d7-b134a5fd0894 2026-07-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216376 application number: ANDA216376 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE QUAGEN PHARMACEUTICALS LLC 5f3c7457-6670-4a0d-bdff-c3e0fe91b7c6 2023-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216376 application number: ANDA216376 ndc (product): 70752-141
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70752-141-10 70752014110 100 CAPSULE in 1 BOTTLE, PLASTIC (70752-141-10) 100 capsule 2022-08-06 No No Current 70752-141-14 70752014114 500 CAPSULE in 1 BOTTLE, PLASTIC (70752-141-14) 500 capsule 2022-08-06 No No Current