NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1232Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1232Add 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 NDC11-digit (billing)PackageCopy
72162-1232-172162123201100 CAPSULE in 1 BOTTLE (72162-1232-1)Marketed from Oct 2, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Acetaminophen — 300 mg/1Caffeine — 40 mg/1Butalbital — 50 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207118
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers
Product ID 72162-1232_e830bb30-27d1-4b2b-abfe-2ac29e0b9defSPL ID e830bb30-27d1-4b2b-abfe-2ac29e0b9defSPL set ID 3fe91e9f-4033-4b48-b51b-7eb67d40fa3aRxCUI 889520UNII 362O9ITL9D, 3G6A5W338E, KHS0AZ4JVK
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

N472162123201 followed by a unit qualifier and the quantity

Package 72162-1232-01. 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 . 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 207118

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

FDA NDC Directory listings under ANDA 207118
ProductStrengthForm · routeLabelerProduct NDC
Butalbital, Acetaminophen And CaffeineAcetaminophen 300 mg/1 + 2 more ingredientsCapsuleOralBryant Ranch Prepack63629-2372
Butalbital, Acetaminophen And CaffeineAcetaminophen 300 mg/1 + 2 more ingredientsCapsuleOralSUNRISE PHARMACEUTICAL, INC11534-187

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