Butalbital, Acetaminophen, and Caffeine NDC 68071-3249

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3249Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3249Add 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
68071-3249-0	68071324900	10 TABLET in 1 BOTTLE (68071-3249-0)Marketed from Aug 16, 2017
68071-3249-2	68071324902	20 TABLET in 1 BOTTLE (68071-3249-2)Marketed from May 5, 2017
68071-3249-3	68071324903	30 TABLET in 1 BOTTLE (68071-3249-3)Marketed from May 5, 2017
68071-3249-6	68071324906	60 TABLET in 1 BOTTLE (68071-3249-6)Marketed from May 5, 2017

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 — 325 mg/1Butalbital — 50 mg/1Caffeine — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200243
Marketing start: Sep 13, 2012
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 68071-3249_2abc72f5-d1fe-c4f4-e063-6394a90aab9aSPL ID 2abc72f5-d1fe-c4f4-e063-6394a90aab9aSPL set ID 4ecb7bdc-4a43-7444-e054-00144ff88e88RxCUI 238154UNII 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338EUPC 0368071324938
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

N468071324900 followed by a unit qualifier and the quantity

Package 68071-3249-00. 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 2, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen, and caffeine tablets, 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 200243

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

FDA NDC Directory listings under ANDA 200243
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Proficient Rx LP	63187-933
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Cardinal Health 107, LLC	55154-3356
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	63629-8392
Butal/APAP/Caff	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Direct_Rx	72189-441
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Lannett Company, Inc.	0527-1695
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	REMEDYREPACK INC.	70518-1134
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Major Pharmaceuticals	0904-6938