What is NDC 0527-1695?

0527-1695 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Lannett Company, Inc., NDC labeler code 0527. 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 0527-1695

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1695Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1695Add 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
0527-1695-01	0052716950100527169501	100 TABLET in 1 BOTTLE, PLASTIC (0527-1695-01)Marketed from Sep 13, 2012
0527-1695-05	0052716950500527169505	500 TABLET in 1 BOTTLE, PLASTIC (0527-1695-05)Marketed from Sep 13, 2012

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: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200243
Marketing start: Sep 13, 2012
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 0527-1695_315b8ce7-eba3-4035-a5ab-4853ba0bb646SPL ID 315b8ce7-eba3-4035-a5ab-4853ba0bb646SPL set ID 42594152-563e-4984-9901-d6ef3b8a6941RxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E
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

N400527169501 followed by a unit qualifier and the quantity

Package 00527-1695-01. 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 Aug 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen, and caffeine tablets, 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 0527-1695

What is NDC 0527-1695?: 0527-1695 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Lannett Company, 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?: Lannett Company, Inc., NDC labeler code 0527. 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 200243

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

FDA NDC Directory listings under ANDA 200243
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Bryant Ranch Prepack	63629-8392
Butalbital, Acetaminophen, and Caffeine	Acetaminophen 325 mg/1 + 2 more ingredients	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3249
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	REMEDYREPACK INC.	70518-1134
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Cardinal Health 107, LLC	55154-3356
Butal/APAP/Caff	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Direct_Rx	72189-441
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Major Pharmaceuticals	0904-6938
Butalbital, Acetaminophen, and Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Proficient Rx LP	63187-933