Metronidazole NDC 50090-7345

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7345Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7345Add 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
50090-7345-0	50090734500	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-7345-0) / 70 g in 1 TUBE, WITH APPLICATORMarketed from Oct 16, 2024

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: Vaginal
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215794
Marketing start: Jan 27, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 50090-7345_2a62e93e-8c7d-41c9-92bd-1a9bd2cc631aSPL ID 2a62e93e-8c7d-41c9-92bd-1a9bd2cc631aSPL set ID e6ece591-38fa-4016-bd62-d31a3e5a8da3RxCUI 142046UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N450090734500 followed by a unit qualifier and the quantity

Package 50090-7345-00. 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 Oct 21, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215794

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

FDA NDC Directory listings under ANDA 215794
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 7.5 mg/g	GelVaginal	GLENMARK PHARMACEUTICALS INC., USA	68462-184
Metronidazole	Metronidazole 7.5 mg/g	GelVaginal	A-S Medication Solutions	50090-7160
Metronidazole	Metronidazole 7.5 mg/g	GelVaginal	Northstar Rx LLC	16714-557