What is NDC 52544-080?

52544-080 is the product NDC for Fioricet, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Fioricet (Butalbital, Acetaminophen, and Caffeine).

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Actavis Pharma, Inc., NDC labeler code 52544. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fioricet?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fioricet NDC 52544-080 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52544-080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52544-0080Add 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
52544-080-01	5254400800152544008001	100 CAPSULE in 1 BOTTLE (52544-080-01)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
Generic name (nonproprietary): butalbital, acetaminophen, and caffeine
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 52544
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040885
Marketing start: Jul 29, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 52544-080_b31b5178-c2d3-4d0c-9e68-95acc212a74aSPL ID b31b5178-c2d3-4d0c-9e68-95acc212a74aSPL set ID c018be7d-f7b8-45e2-97b8-8e7a71740657RxCUI 889520, 1432261UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338EUPC 0352544080018
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

N452544008001 followed by a unit qualifier and the quantity

Package 52544-0080-01. 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 Dec 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fioricet is 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)

About NDC 52544-080

What is NDC 52544-080?: 52544-080 is the product NDC for Fioricet, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fioricet (Butalbital, Acetaminophen, and Caffeine).
What is the active ingredient?: Butalbital, Acetaminophen, Caffeine.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 52544. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fioricet?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 040885

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

FDA NDC Directory listings under ANDA 040885
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Actavis Pharma, Inc.	0591-2640
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	AvKARE	42291-181

Fioricet (Butalbital, acetaminophen, and caffeine) NDC 52544-080