Butalbital, Acetaminophen and Caffeine NDC 70010-149

NDC codes

FDA NDC Directory

Product NDC (as listed)70010-149Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70010-0149Add 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
70010-149-01	70010014901	100 TABLET in 1 BOTTLE (70010-149-01)Marketed from Jun 29, 2022
70010-149-05	70010014905	500 TABLET in 1 BOTTLE (70010-149-05)Marketed from Jun 29, 2022

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: Granules Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040864
Marketing start: Jun 29, 2022
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 70010-149_f33d40cf-0771-0e21-e053-2a95a90aa8edSPL ID f33d40cf-0771-0e21-e053-2a95a90aa8edSPL set ID 74e27dab-9790-47e4-b4f1-3b9df4bce184RxCUI 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

N470010014901 followed by a unit qualifier and the quantity

Package 70010-0149-01. 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 Jan 27, 2023. 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 butalbital, acetaminophen, and caffeine tablets 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 040864

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

FDA NDC Directory listings under ANDA 040864
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Golden State Medical Supply, Inc.	51407-556
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-865
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	71335-2270
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	71335-2272