butalbital, acetaminophen and caffeine NDC 63187-520

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-520Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0520Add 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
63187-520-30	63187052030	30 TABLET in 1 BOTTLE, PLASTIC (63187-520-30)Marketed from Dec 1, 2018
63187-520-60	63187052060	60 TABLET in 1 BOTTLE, PLASTIC (63187-520-60)Marketed from Dec 1, 2018
63187-520-90	63187052090	90 TABLET in 1 BOTTLE, PLASTIC (63187-520-90)Marketed from Dec 1, 2018

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/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089175
Marketing start: Jan 21, 1987
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 63187-520_42b76389-6fa2-49a5-b435-672d3862c6f3SPL ID 42b76389-6fa2-49a5-b435-672d3862c6f3SPL set ID 1bde13a5-cdd4-4bc2-8aeb-32e4dc157293RxCUI 238154UNII 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

N463187052030 followed by a unit qualifier and the quantity

Package 63187-0520-30. 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 Jan 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine tablets 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 089175

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

FDA NDC Directory listings under ANDA 089175
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Chartwell RX, LLC	62135-751
butalbital, acetaminophen and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Mikart, LLC	46672-053