What is NDC 80425-0497?

80425-0497 is the product NDC for Butalbital, Acetaminophen And Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Butalbital, Acetaminophen And Caffeine?

50 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Butalbital, Acetaminophen And Caffeine NDC 80425-0497

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0497Add 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
80425-0497-1	8042504970180425049701	30 CAPSULE in 1 BOTTLE (80425-0497-1)Marketed from Feb 14, 2025

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 — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214087
Marketing start: Feb 14, 2025
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 80425-0497_2e20e0f9-ff3c-5d55-e063-6294a90a13ebSPL ID 2e20e0f9-ff3c-5d55-e063-6294a90a13ebSPL set ID 2e20e0ee-dd73-6287-e063-6294a90a03b1RxCUI 889520UNII 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

N480425049701 followed by a unit qualifier and the quantity

Package 80425-0497-01. 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 Feb 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine capsules are 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 80425-0497

What is NDC 80425-0497?: 80425-0497 is the product NDC for Butalbital, Acetaminophen And Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Butalbital, Acetaminophen And Caffeine.
What is the active ingredient?: Butalbital, Acetaminophen, Caffeine.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Butalbital, Acetaminophen And Caffeine?: 50 other product NDCs are listed under this name. See all Butalbital, Acetaminophen And Caffeine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Butalbital, Acetaminophen And Caffeine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Preferred Pharmaceuticals Inc.	68788-4126	68788-4126-0268788-4126-03
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	REMEDYREPACK INC.	70518-4601	70518-4601-0070518-4601-0170518-4601-02
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Amici Pharma, Inc.	69292-305	69292-0305-01
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Advanced Rx of Tennessee, LLC	80425-0567	80425-0567-0180425-0567-0280425-0567-03
Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/15mL + 2 more ingredients	SolutionOral	Genus Lifesciences Inc.	64950-290	64950-0290-16
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Preferred Pharmaceuticals Inc.	68788-8794	68788-8794-0268788-8794-03
butalbital, acetaminophen and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-009	75907-0009-01
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	QUAGEN PHARMACEUTICALS LLC	70752-142	70752-0142-1070752-0142-14
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	QUAGEN PHARMACEUTICALS LLC	70752-144	70752-0144-1070752-0144-14
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	71335-2546	71335-2546-0071335-2546-0171335-2546-02+7 more

All 51 Butalbital, Acetaminophen And Caffeine NDCs

Other NDCs under ANDA 214087

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

FDA NDC Directory listings under ANDA 214087
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Seton Pharmaceuticals LLC	13925-535
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Seton Pharmaceuticals LLC	13925-536
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	SOLCO HEALTHCARE US, LLC	43547-686
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Amici Pharma, Inc.	69292-305