What is NDC 0591-3369?

0591-3369 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Actavis Pharma, Inc., NDC labeler code 0591. 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, and Caffeine?

50 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, and Caffeine NDC 0591-3369

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3369Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3369Add 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
0591-3369-01	0059133690100591336901	100 TABLET in 1 BOTTLE (0591-3369-01)Marketed from Dec 13, 2007
0591-3369-05	0059133690500591336905	500 TABLET in 1 BOTTLE (0591-3369-05)Marketed from Dec 13, 2007

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, Acetaminophen, and Caffeine
Generic name (nonproprietary): butalbital, acetaminophen, and caffeine
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088616
Marketing start: Dec 13, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 0591-3369_44b619cd-6f35-43c0-893b-9d72c049fed4SPL ID 44b619cd-6f35-43c0-893b-9d72c049fed4
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

N400591336901 followed by a unit qualifier and the quantity

Package 00591-3369-01. 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 0591-3369

What is NDC 0591-3369?: 0591-3369 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Butalbital, Acetaminophen, and Caffeine.
What is the active ingredient?: Butalbital, Acetaminophen, Caffeine.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. 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, and Caffeine?: 50 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, 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, Acetaminophen, and Caffeine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Butalbital, Acetaminophen and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Preferred Pharmaceuticals Inc.	68788-4126	68788-4126-0268788-4126-03
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	REMEDYREPACK INC.	70518-4601	70518-4601-0070518-4601-0170518-4601-02
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Amici Pharma, Inc.	69292-305	69292-0305-01
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Advanced Rx of Tennessee, LLC	80425-0567	80425-0567-0180425-0567-0280425-0567-03
Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine	Butalbital 50 mg/15mL + 2 more ingredients	SolutionOral	Genus Lifesciences Inc.	64950-290	64950-0290-16
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0497	80425-0497-01
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Preferred Pharmaceuticals Inc.	68788-8794	68788-8794-0268788-8794-03
butalbital, acetaminophen and caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-009	75907-0009-01
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	QUAGEN PHARMACEUTICALS LLC	70752-142	70752-0142-1070752-0142-14
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	CapsuleOral	QUAGEN PHARMACEUTICALS LLC	70752-144	70752-0144-1070752-0144-14

All 51 Butalbital, Acetaminophen, and Caffeine NDCs