What is NDC 80425-0215?

80425-0215 is the product NDC for Butalbital/Acetaminophen/Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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/Caffeine?

12 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/Caffeine NDC 80425-0215

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0215Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0215Add 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
80425-0215-1	80425021501	30 CAPSULE in 1 BOTTLE (80425-0215-1)Marketed from Jan 3, 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/Caffeine
Generic name (nonproprietary): butalbital/acetaminophen/caffeine
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213321
Marketing start: Jan 3, 2023
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 80425-0215_2a9aa22e-db3d-217b-e063-6294a90a4c41SPL ID 2a9aa22e-db3d-217b-e063-6294a90a4c41SPL set ID f16429e2-4944-5bbc-e053-2a95a90ab528RxCUI 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

N480425021501 followed by a unit qualifier and the quantity

Package 80425-0215-01. 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 31, 2024.

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 80425-0215

What is NDC 80425-0215?: 80425-0215 is the product NDC for Butalbital/Acetaminophen/Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Advanced Rx Pharmacy 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/Caffeine.
What is the active ingredient?: Butalbital, Acetaminophen, Caffeine.
Who is the labeler?: Advanced Rx Pharmacy 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/Caffeine?: 12 other product NDCs are listed under this name. See all Butalbital/Acetaminophen/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/Caffeine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Advanced Rx of Tennessee, LLC	80425-0570	80425-0570-0180425-0570-0280425-0570-03
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	REMEDYREPACK INC.	70518-4309	70518-4309-0070518-4309-01
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	AvPAK	50268-553	50268-0553-13
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Preferred Pharmaceuticals Inc.	68788-8137	68788-8137-0268788-8137-03
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	71335-1764	71335-1764-0071335-1764-0171335-1764-02+7 more
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	71335-1767	71335-1767-0071335-1767-0171335-1767-02+7 more
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	A-S Medication Solutions	50090-7042	50090-7042-0050090-7042-03
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Asclemed USA, Inc.	76420-802	76420-0802-0176420-0802-0576420-0802-10+5 more
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Proficient Rx LP	71205-981	71205-0981-0071205-0981-3071205-0981-55+3 more
Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	HAWAII REPACK, INC.	85534-0046	85534-0046-0085534-0046-0185534-0046-02+6 more

All 13 Butalbital/Acetaminophen/Caffeine NDCs

Other NDCs under ANDA 213321

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

FDA NDC Directory listings under ANDA 213321
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Granules Pharmaceuticals Inc.	70010-044