What is NDC 68047-721?

68047-721 is the product NDC for Butalbital And Acetaminophen, Butalbital 50 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Larken Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Larken Laboratories, Inc., NDC labeler code 68047. 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 68047-721

NDC codes

FDA NDC Directory

Product NDC (as listed)68047-721Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68047-0721Add 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
68047-721-01	6804707210168047072101	100 TABLET in 1 BOTTLE (68047-721-01)Marketed from Dec 4, 2015
68047-721-30	6804707213068047072130	30 TABLET in 1 BOTTLE (68047-721-30)Marketed from Dec 4, 2015

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: Butalbital — 50 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Larken Laboratories, Inc.NDC labeler code 68047
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203484
Marketing start: Dec 4, 2015
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)
Identifiers: Product ID 68047-721_41348343-4fef-7234-e063-6394a90af41dSPL ID 41348343-4fef-7234-e063-6394a90af41dSPL set ID 326c83fc-afed-45ad-9c87-f47968fa1d2aRxCUI 197426, 1724446, 2279007UNII 362O9ITL9D, KHS0AZ4JVKUPC 0368047753014, 0368047752017, 0368047721013
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

N468047072101 followed by a unit qualifier and the quantity

Package 68047-0721-01. 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 Oct 15, 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 68047-721

What is NDC 68047-721?: 68047-721 is the product NDC for Butalbital And Acetaminophen, Butalbital 50 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Larken Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Butalbital And Acetaminophen.
What is the active ingredient?: Butalbital, Acetaminophen.
Who is the labeler?: Larken Laboratories, Inc., NDC labeler code 68047. 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	Acetaminophen 300 mg/1; Butalbital 50 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-123	81005-0123-01
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

All 14 Butalbital And Acetaminophen NDCs

Other NDCs under ANDA 203484

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

FDA NDC Directory listings under ANDA 203484
Product	Strength	Form · route	Labeler	Product NDC
Allzitalbutalbital and acetaminophen	Butalbital 25 mg/1; Acetaminophen 325 mg/1	TabletOral	Larken Laboratories, Inc.	68047-752
Butalbital and Acetaminophen	Butalbital 25 mg/1; Acetaminophen 325 mg/1	TabletOral	Larken Laboratories, Inc.	68047-753