What is NDC 11534-187?

11534-187 is the product NDC for Butalbital, Acetaminophen And Caffeine, Acetaminophen 300 mg/1 + 2 more ingredients capsule, listed with the FDA by SUNRISE PHARMACEUTICAL, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Caffeine, Butalbital.

SUNRISE PHARMACEUTICAL, INC, NDC labeler code 11534. 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 11534-187

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-187Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0187Add 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
11534-187-01	1153401870111534018701	100 CAPSULE in 1 BOTTLE (11534-187-01)Marketed from Jan 10, 2017
11534-187-04	1153401870411534018704	500 CAPSULE in 1 BOTTLE (11534-187-04)Marketed from Jan 10, 2017

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, Acetaminophen And Caffeine
Generic name (nonproprietary): butalbital, acetaminophen and caffeine
Active ingredients: Acetaminophen — 300 mg/1Caffeine — 40 mg/1Butalbital — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: SUNRISE PHARMACEUTICAL, INCNDC labeler code 11534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207118
Marketing start: Jan 10, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 11534-187_7b8cb532-14e4-4cc6-b799-6855a0c10b14SPL ID 7b8cb532-14e4-4cc6-b799-6855a0c10b14SPL set ID ee7630f8-f4b8-4eb0-b34d-d908567030c4RxCUI 889520UNII 362O9ITL9D, 3G6A5W338E, KHS0AZ4JVKUPC 0311534187045, 0311534187014
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

N411534018701 followed by a unit qualifier and the quantity

Package 11534-0187-01. 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 Jan 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, USP 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 11534-187

What is NDC 11534-187?: 11534-187 is the product NDC for Butalbital, Acetaminophen And Caffeine, Acetaminophen 300 mg/1 + 2 more ingredients capsule, listed with the FDA by SUNRISE PHARMACEUTICAL, 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?: Acetaminophen, Caffeine, Butalbital.
Who is the labeler?: SUNRISE PHARMACEUTICAL, INC, NDC labeler code 11534. 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

Other NDCs under ANDA 207118

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

FDA NDC Directory listings under ANDA 207118
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen And Caffeine	Acetaminophen 300 mg/1 + 2 more ingredients	CapsuleOral	Bryant Ranch Prepack	63629-2372
Butalbital, Acetaminophen And Caffeine	Acetaminophen 300 mg/1 + 2 more ingredients	CapsuleOral	Bryant Ranch Prepack	72162-1232