NDC codes

FDA NDC Directory
Product NDC (as listed)62135-751Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0751Add 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 NDC11-digit (billing)PackageCopy
62135-751-0162135075101100 TABLET in 1 BOTTLE (62135-751-01)Marketed from Aug 25, 2023

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
Butalbital50 mg/1Acetaminophen325 mg/1Caffeine40 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 089175
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers
Product ID 62135-751_458c0456-32bb-ff23-e063-6394a90aceeaSPL ID 458c0456-32bb-ff23-e063-6394a90aceeaSPL set ID 77776146-c6e6-478c-b30e-2b729e758400RxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338EUPC 0362135751012
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

N462135075101 followed by a unit qualifier and the quantity

Package 62135-0751-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine tablets 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)

Other NDCs under ANDA 089175

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

FDA NDC Directory listings under ANDA 089175
ProductStrengthForm · routeLabelerProduct NDC
butalbital, acetaminophen and caffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralMikart, LLC46672-053
butalbital, acetaminophen and caffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralProficient Rx LP63187-520

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