What is NDC 0781-2270?

0781-2270 is the product NDC for Butalbital, aspirin, and caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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, aspirin, and caffeine?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Butalbital, aspirin, and caffeine NDC 0781-2270

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-2270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-2270Add 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
0781-2270-01	00781227001	100 CAPSULE in 1 BOTTLE (0781-2270-01)Marketed from Sep 3, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Butalbital, aspirin, and caffeine
Generic name (nonproprietary): butalbital, aspirin, and caffeine
Active ingredients: Butalbital — 50 mg/1Aspirin — 325 mg/1Caffeine — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 086996
Marketing start: Sep 3, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Non-Steroidal (Chemical structure)Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 0781-2270_e179c768-32ba-49b7-b59a-55b2cfa54619SPL ID e179c768-32ba-49b7-b59a-55b2cfa54619SPL set ID 0e5e3842-fc6c-4a24-8e5c-522701f7c291RxCUI 238134UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E
Pharmacologic class: Barbiturate; Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor

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

N400781227001 followed by a unit qualifier and the quantity

Package 00781-2270-01. 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 2, 2024.

Indications (excerpt from the label)

INDICATIONS Butalbital, aspirin, 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 butalbital, aspirin, and caffeine capsules 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 0781-2270

What is NDC 0781-2270?: 0781-2270 is the product NDC for Butalbital, aspirin, and caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Butalbital, aspirin, and caffeine.
What is the active ingredient?: Butalbital, Aspirin, Caffeine.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. 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, aspirin, and caffeine?: 4 other product NDCs are listed under this name. See all Butalbital, aspirin, 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, aspirin, and caffeine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Butalbital, Aspirin, And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Westminster Pharmaceuticals, LLC	69367-416	69367-0416-01
Butalbital, Aspirin, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-7192	79739-7192-0179739-7192-05
Butalbital, aspirin, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Lannett Company, Inc.	0527-1552	00527-1552-01
butalbital, aspirin, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Chartwell RX, LLC	62135-433	62135-0433-90

Other NDCs under ANDA 086996

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

FDA NDC Directory listings under ANDA 086996
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, aspirin, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Lannett Company, Inc.	0527-1552
butalbital, aspirin, and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Chartwell RX, LLC	62135-433