NDC codes

FDA NDC Directory
Product NDC (as listed)67296-2121Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-2121Add 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
67296-2121-4672962121041 TUBE in 1 CARTON (67296-2121-4) / 45 g in 1 TUBEMarketed from Jul 18, 2006

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Metronidazole
Generic name (nonproprietary)
metronidazole
Active ingredients
Metronidazole — 7.5 mg/g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077819
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 67296-2121_4698aee4-760c-5242-e063-6394a90a9c73SPL ID 4698aee4-760c-5242-e063-6394a90a9c73SPL set ID 300b51d0-8fca-24ef-e063-6294a90ad2b9RxCUI 311679UNII 140QMO216E
Pharmacologic class
Nitroimidazole Antimicrobial

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N467296212104 followed by a unit qualifier and the quantity

Package 67296-2121-04. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077819

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

FDA NDC Directory listings under ANDA 077819
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 7.5 mg/gGelTopicalSun Pharmaceutical Industries, Inc.51672-4116

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