What is NDC 70010-054?

70010-054 is the product NDC for butalbital and acetaminophen, Butalbital 50 mg/1; Acetaminophen 300 mg/1 capsule, listed with the FDA by Granules Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Granules Pharmaceuticals Inc., NDC labeler code 70010. 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 70010-054

NDC codes

FDA NDC Directory

Product NDC (as listed)70010-054Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70010-0054Add 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
70010-054-01	7001000540170010005401	100 CAPSULE in 1 BOTTLE (70010-054-01)Marketed from Jan 20, 2020
70010-054-05	7001000540570010005405	500 CAPSULE in 1 BOTTLE (70010-054-05)Marketed from Jan 20, 2020

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 — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Granules Pharmaceuticals Inc.NDC labeler code 70010
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213115
Marketing start: Jan 20, 2020
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)
Identifiers: Product ID 70010-054_5d4eb4aa-5315-85c1-e063-6394a90aef9dSPL ID 5d4eb4aa-5315-85c1-e063-6394a90aef9d
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

N470010005401 followed by a unit qualifier and the quantity

Package 70010-0054-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70010-054

What is NDC 70010-054?: 70010-054 is the product NDC for butalbital and acetaminophen, Butalbital 50 mg/1; Acetaminophen 300 mg/1 capsule, listed with the FDA by Granules Pharmaceuticals 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?: Granules Pharmaceuticals Inc., NDC labeler code 70010. 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 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