Fioricet with Codeine NDC 52544-082

NDC codes

FDA NDC Directory

Product NDC (as listed)52544-082Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52544-0082Add 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
52544-082-01	52544008201	100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01)Marketed from Jul 29, 2013

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): Fioricet with Codeine
Generic name (nonproprietary): butalbital, acetaminophen, caffeine, and codeine phosphate
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076560
Marketing start: Jul 29, 2013
Marketing end: Sep 30, 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 52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74aSPL ID c5c3390f-a64b-49cb-8fcb-5762dc8ee74aSPL set ID df9801fc-03fe-41da-a6b3-0f76788217c9RxCUI 1431286, 1433802UNII 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

N452544008201 followed by a unit qualifier and the quantity

Package 52544-0082-01. 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 Mar 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve FIORICET with CODEINE for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. FIORICET with CODEINE is a combination product of butalb…

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
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital 50 mg/1 + 3 more ingredients	CapsuleOral	Bryant Ranch Prepack	72162-1591
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