Butalbital, Acetaminophen and Caffeine NDC 71335-2270

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2270Add 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
71335-2270-0	71335227000	84 TABLET in 1 BOTTLE (71335-2270-0)Marketed from Nov 30, 2023
71335-2270-1	71335227001	20 TABLET in 1 BOTTLE (71335-2270-1)Marketed from Nov 30, 2023
71335-2270-2	71335227002	30 TABLET in 1 BOTTLE (71335-2270-2)Marketed from Nov 30, 2023
71335-2270-3	71335227003	60 TABLET in 1 BOTTLE (71335-2270-3)Marketed from Nov 30, 2023
71335-2270-4	71335227004	90 TABLET in 1 BOTTLE (71335-2270-4)Marketed from Nov 30, 2023
71335-2270-5	71335227005	50 TABLET in 1 BOTTLE (71335-2270-5)Marketed from Nov 30, 2023
71335-2270-6	71335227006	6 TABLET in 1 BOTTLE (71335-2270-6)Marketed from Nov 30, 2023
71335-2270-7	71335227007	120 TABLET in 1 BOTTLE (71335-2270-7)Marketed from Nov 30, 2023
71335-2270-8	71335227008	40 TABLET in 1 BOTTLE (71335-2270-8)Marketed from Nov 30, 2023
71335-2270-9	71335227009	12 TABLET in 1 BOTTLE (71335-2270-9)Marketed from Nov 30, 2023

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: Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
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 71335-2270_0e3608c9-b97a-4f77-9cd8-d63f6d55cab1SPL ID 0e3608c9-b97a-4f77-9cd8-d63f6d55cab1SPL set ID b94ab2bc-6ef3-4a64-ba05-a0a4e37794faRxCUI 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

N471335227000 followed by a unit qualifier and the quantity

Package 71335-2270-00. 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 Nov 30, 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	Granules Pharmaceuticals Inc.	70010-149
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	71335-2272