Butalbital, Acetaminophen, Caffeine and Codeine Phosphate NDC 72162-1591

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-1591Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-1591Add 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
72162-1591-2	72162159102	20 CAPSULE in 1 BOTTLE, PLASTIC (72162-1591-2)Marketed from Apr 4, 2024

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, Caffeine and Codeine Phosphate
Generic name (nonproprietary): butalbital, acetaminophen, caffeine and codeine phosphate
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076560
Marketing start: Jul 1, 2004
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
Identifiers: Product ID 72162-1591_215e2a6f-ec32-4836-8fad-22c8b40ba1f1SPL ID 215e2a6f-ec32-4836-8fad-22c8b40ba1f1SPL set ID 215e2a6f-ec32-4836-8fad-22c8b40ba1f1RxCUI 993943UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E, GSL05Y1MN6
Pharmacologic class: Barbiturate; Central Nervous System Stimulant; Methylxanthine; Opioid Agonist

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

N472162159102 followed by a unit qualifier and the quantity

Package 72162-1591-02. 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 Apr 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076560

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

FDA NDC Directory listings under ANDA 076560
Product	Strength	Form · route	Labeler	Product NDC
Fioricet with Codeinebutalbital, acetaminophen, caffeine, and codeine phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	Actavis Pharma, Inc.	52544-082
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-6670
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	Bryant Ranch Prepack	71335-0194
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	Actavis Pharma, Inc.	0591-2641
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	Breckenridge Pharmaceutical, Inc.	51991-073