Butalbital, Acetaminophen And Caffeine NDC 43547-686

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-686Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0686Add 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
43547-686-10	43547068610	100 CAPSULE in 1 BOTTLE (43547-686-10)Marketed from Dec 5, 2023

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 — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: SOLCO HEALTHCARE US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214087
Marketing start: Dec 5, 2023
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 43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60SPL ID f0520093-dfda-4a04-85c4-9ef3c23a8b60SPL set ID 5c9c3407-212a-4ae9-a574-2b0c53f3c5ebRxCUI 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

N443547068610 followed by a unit qualifier and the quantity

Package 43547-0686-10. 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 Sep 10, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214087

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

FDA NDC Directory listings under ANDA 214087
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0497
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Seton Pharmaceuticals LLC	13925-535
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Seton Pharmaceuticals LLC	13925-536
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Amici Pharma, Inc.	69292-305