NDC codes

FDA NDC Directory
Product NDC (as listed)68047-752Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68047-0752Add 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
68047-752-0168047075201100 TABLET in 1 BOTTLE (68047-752-01)Marketed from Dec 4, 2015
68047-752-306804707523030 TABLET in 1 BOTTLE (68047-752-30)Marketed from Dec 4, 2015

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)
Allzital
Generic name (nonproprietary)
butalbital and acetaminophen
Active ingredients
Butalbital — 25 mg/1Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203484
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Barbiturates (Chemical structure)
Identifiers
Product ID 68047-752_41348343-4fef-7234-e063-6394a90af41dSPL ID 41348343-4fef-7234-e063-6394a90af41dSPL set ID 326c83fc-afed-45ad-9c87-f47968fa1d2aRxCUI 197426, 1724446, 2279007UNII KHS0AZ4JVK, 362O9ITL9DUPC 0368047753014, 0368047752017, 0368047721013
Pharmacologic class
Barbiturate

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

N468047075201 followed by a unit qualifier and the quantity

Package 68047-0752-01. 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 and Acetaminophen 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 203484

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

FDA NDC Directory listings under ANDA 203484
ProductStrengthForm · routeLabelerProduct NDC
Butalbital And AcetaminophenButalbital 50 mg/1; Acetaminophen 325 mg/1TabletOralLarken Laboratories, Inc.68047-721
Butalbital and AcetaminophenButalbital 25 mg/1; Acetaminophen 325 mg/1TabletOralLarken Laboratories, Inc.68047-753

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