Butalbital, Acetaminophen, and Caffeine NDC 0527-4095

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-4095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-4095Add 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
0527-4095-37	00527409537	100 CAPSULE in 1 BOTTLE (0527-4095-37)Marketed from Dec 17, 2019

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 capsules
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212082
Marketing start: Dec 17, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 0527-4095_146b5639-6699-471c-ae28-1f576bbead9fSPL ID 146b5639-6699-471c-ae28-1f576bbead9fSPL set ID 4d62259d-a582-4621-b62e-3d5640cadf7cRxCUI 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

N400527409537 followed by a unit qualifier and the quantity

Package 00527-4095-37. 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, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine capsules 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.

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