Butalbital, Acetaminophen, and Caffeine NDC 0591-2640

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2640Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2640Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0591-2640-01	00591264001	100 CAPSULE in 1 BOTTLE (0591-2640-01)Marketed from Jul 29, 2013
0591-2640-05	00591264005	500 CAPSULE in 1 BOTTLE (0591-2640-05)Marketed from Jul 29, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Butalbital, Acetaminophen, and Caffeine
Generic name (nonproprietary): butalbital, acetaminophen, and caffeine
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040885
Marketing start: Jul 29, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 0591-2640_62e81b0e-5abd-49ef-9131-10ebdd923c1fSPL ID 62e81b0e-5abd-49ef-9131-10ebdd923c1fSPL set ID ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35RxCUI 889520UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E
Pharmacologic class: Barbiturate; Central Nervous System Stimulant; Methylxanthine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400591264001 followed by a unit qualifier and the quantity

Package 00591-2640-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040885

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040885
Product	Strength	Form · route	Labeler	Product NDC
Fioricetbutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Actavis Pharma, Inc.	52544-080
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	AvKARE	42291-181