NDC product

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

NDC 11534-187 · SUNRISE PHARMACEUTICAL, INC

Key facts

Product NDC 11534-187
Proprietary name BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Nonproprietary name butalbital, acetaminophen and caffeine
Substances ACETAMINOPHEN, CAFFEINE, BUTALBITAL
Dosage form CAPSULE
Route ORAL
Labeler SUNRISE PHARMACEUTICAL, INC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA207118
DEA schedule CIII
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
Marketing start Jan 10, 2017
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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