Home NDC 68308-554-10 Zebutal
Product NDC 68308-554
Requested package NDC 68308-554-10
11-digit product format 683080554
Labeler code 68308
Product ID 68308-554_ea23bc04-96ae-45e8-e053-2a95a90acd45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Mayne Pharma Inc.
Application ANDA089007
Marketing category ANDA
Marketing start 2013-12-26
Marketing end 2023-10-31
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325 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]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 A089007-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA RS 1986-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089007-001 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 2026-08-01 22:54:32 2026-06 A089007-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA RS 1986-03-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A089007-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Mayne Pharma fa88f437-830b-48bc-a44c-fd142963a150 2025-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089007 application number: ANDA089007 butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Dr. Reddy's Labratories Inc. 69df02fa-c842-48dc-7ac6-5967b7dc30de 2024-08-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089007 application number: ANDA089007
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68308-554-10 68308055410 100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10) 100 capsule 2013-12-26 2023-10-31 No No Current