Metronidazole NDC 62332-016

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0016Add 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
62332-016-30	62332001630	30 TABLET in 1 BOTTLE (62332-016-30)Marketed from Dec 1, 2016
62332-016-31	62332001631	100 TABLET in 1 BOTTLE (62332-016-31)Marketed from Dec 1, 2016
62332-016-50	62332001650	50 TABLET in 1 BOTTLE (62332-016-50)Marketed from Dec 1, 2016
62332-016-61	62332001661	250 TABLET in 1 BOTTLE (62332-016-61)Marketed from Dec 1, 2016
62332-016-71	62332001671	500 TABLET in 1 BOTTLE (62332-016-71)Marketed from Dec 1, 2016
62332-016-91	62332001691	1000 TABLET in 1 BOTTLE (62332-016-91)Marketed from Dec 1, 2016

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): Metronidazole
Generic name (nonproprietary): metronidazole
Active ingredients: Metronidazole — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079067
Marketing start: Dec 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888SPL ID d9dfe831-5b39-4e51-bf18-3846c3469888SPL set ID b1fcf023-cdfd-45b7-b4d4-ff814f33ee79RxCUI 311681, 314106UNII 140QMO216EUPC 0362332016303, 0362332017300
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462332001630 followed by a unit qualifier and the quantity

Package 62332-0016-30. 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 Jul 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079067

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

FDA NDC Directory listings under ANDA 079067
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-007
Metronidazole	Metronidazole 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5073
Metronidazole	Metronidazole 250 mg/1	TabletOral	AvPAK	50268-534
Metronidazole	Metronidazole 500 mg/1	TabletOral	AvPAK	50268-535
Metronidazole	Metronidazole 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2288
Metronidazole	Metronidazole 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-011
Metronidazole	Metronidazole 500 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-017
Metronidazole	Metronidazole 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-1681
Metronidazole	Metronidazole 250 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-428
Metronidazole	Metronidazole 500 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-429