Butalbital, Acetaminophen, Caffeine (Butalbital, acetaminophen, and caffeine) NDC 76420-802

Product information

Brand name (proprietary)

Butalbital, Acetaminophen, 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

Asclemed USA, Inc.NDC labeler code 76420

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 209587

Marketing start

Mar 5, 2019

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 76420-802_44818491-48a2-ba4d-e063-6394a90a65f9SPL ID 44818491-48a2-ba4d-e063-6394a90a65f9SPL set ID cce09e09-158f-4927-8a3e-4ec9334f0b7aRxCUI 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

N476420080201 followed by a unit qualifier and the quantity Copy

Package 76420-0802-01. 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

About NDC 76420-802

What is NDC 76420-802?

76420-802 is the product NDC for Butalbital, Acetaminophen, Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Asclemed USA, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Butalbital, Acetaminophen, Caffeine (Butalbital, Acetaminophen, and Caffeine).

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Who is the labeler?

Asclemed USA, Inc., NDC labeler code 76420. 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, Caffeine?

12 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, Caffeine NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Butalbital, Acetaminophen, Caffeine products

Other finished products listed under the same name: strengths, forms and labelers.

All 13 Butalbital, Acetaminophen, Caffeine NDCs

Other NDCs under ANDA 209587

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