Butalbital, Acetaminophen and Caffeine NDC 64950-290

NDC codes

FDA NDC Directory

Product NDC (as listed)64950-290Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64950-0290Add 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
64950-290-16	64950029016	473 mL in 1 BOTTLE (64950-290-16)Marketed from Jul 1, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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/15mLAcetaminophen — 325 mg/15mLCaffeine — 40 mg/15mL
Dosage form: Solution
Route: Oral
Labeler: Genus Lifesciences Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040387
Marketing start: Jul 1, 2025
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 64950-290_791945e1-c3fd-491b-9593-292a6d07bdb6SPL ID 791945e1-c3fd-491b-9593-292a6d07bdb6SPL set ID 5f603b0d-69e5-4c02-b6b3-b4705e243e9aRxCUI 756245UNII 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

N464950029016 followed by a unit qualifier and the quantity

Package 64950-0290-16. 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 Jul 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine oral solution is 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)