What is NDC 81005-123?

81005-123 is the product NDC for Butalbital And Acetaminophen, Acetaminophen 300 mg/1; Butalbital 50 mg/1 tablet, listed with the FDA by Aarkish Pharmaceuticals NJ Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Aarkish Pharmaceuticals NJ Inc., NDC labeler code 81005. 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 And Acetaminophen?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Butalbital And Acetaminophen NDC 81005-123

NDC codes

FDA NDC Directory

Product NDC (as listed)81005-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81005-0123Add 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
81005-123-01	8100501230181005012301	100 TABLET in 1 BOTTLE (81005-123-01)Marketed from Dec 3, 2024

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): Butalbital And Acetaminophen
Generic name (nonproprietary): butalbital and acetaminophen
Active ingredients: Acetaminophen — 300 mg/1Butalbital — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aarkish Pharmaceuticals NJ Inc.NDC labeler code 81005
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214955
Marketing start: Dec 3, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)
Identifiers: Product ID 81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0eSPL ID 37ca06ac-1f37-4952-e063-6394a90a2a0eSPL set ID 82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6RxCUI 1249617UNII 362O9ITL9D, KHS0AZ4JVK
Pharmacologic class: Barbiturate

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

N481005012301 followed by a unit qualifier and the quantity

Package 81005-0123-01. 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 Jun 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital and Acetaminophen Tablets 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 81005-123

What is NDC 81005-123?: 81005-123 is the product NDC for Butalbital And Acetaminophen, Acetaminophen 300 mg/1; Butalbital 50 mg/1 tablet, listed with the FDA by Aarkish Pharmaceuticals NJ Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Butalbital And Acetaminophen.
What is the active ingredient?: Acetaminophen, Butalbital.
Who is the labeler?: Aarkish Pharmaceuticals NJ Inc., NDC labeler code 81005. 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 And Acetaminophen?: 13 other product NDCs are listed under this name. See all Butalbital And Acetaminophen 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 And Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Butalbital And Acetaminophen	Acetaminophen 300 mg/1; Butalbital 50 mg/1	TabletOral	Amici Pharma, Inc.	69292-301	69292-0301-01
Butalbital And Acetaminophen	Acetaminophen 325 mg/1; Butalbital 50 mg/1	TabletOral	Amici Pharma, Inc.	69292-302	69292-0302-01
Butalbital And Acetaminophen	Acetaminophen 325 mg/1; Butalbital 25 mg/1	TabletOral	Amici Pharma, Inc.	69292-303	69292-0303-01
butalbital and acetaminophen	Butalbital 50 mg/1; Acetaminophen 300 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-008	75907-0008-01
BUTALBITAL and ACETAMINOPHEN	Butalbital 50 mg/1; Acetaminophen 300 mg/1	TabletOral	QUAGEN PHARMACEUTICALS LLC	70752-147	70752-0147-1070752-0147-14
BUTALBITAL and ACETAMINOPHEN	Butalbital 50 mg/1; Acetaminophen 325 mg/1	TabletOral	QUAGEN PHARMACEUTICALS LLC	70752-148	70752-0148-1070752-0148-14
Butalbital And Acetaminophen	Butalbital 50 mg/1; Acetaminophen 300 mg/1	TabletOral	Burel Pharmaceuticals, LLC	35573-455	35573-0455-02
Butalbital And Acetaminophen	Butalbital 50 mg/1; Acetaminophen 325 mg/1	TabletOral	Burel Pharmaceuticals, LLC	35573-456	35573-0456-02
butalbital and acetaminophen	Butalbital 50 mg/1; Acetaminophen 300 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-054	70010-0054-0170010-0054-05
Butalbital and Acetaminophenbutalbital and acetaminophen tablets	Butalbital 50 mg/1; Acetaminophen 300 mg/1	TabletOral	Oceanside Pharmaceuticals	68682-306	68682-0306-01

All 14 Butalbital And Acetaminophen NDCs