Metronidazole NDC 46708-435

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0435Add 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
46708-435-30	46708043530	30 CAPSULE in 1 BOTTLE (46708-435-30)Marketed from Dec 9, 2016
46708-435-31	46708043531	100 CAPSULE in 1 BOTTLE (46708-435-31)Marketed from Dec 9, 2016
46708-435-50	46708043550	50 CAPSULE in 1 BOTTLE (46708-435-50)Marketed from Dec 9, 2016
46708-435-71	46708043571	500 CAPSULE in 1 BOTTLE (46708-435-71)Marketed from Dec 9, 2016
46708-435-91	46708043591	1000 CAPSULE in 1 BOTTLE (46708-435-91)Marketed from Dec 9, 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 — 375 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079065
Marketing start: Dec 9, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1SPL ID 73035cba-781b-4d60-80bb-8f8ff273a0a1SPL set ID 387053e5-7eda-4282-b58a-5789430a2e99RxCUI 199055UNII 140QMO216EUPC 0346708435301
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

N446708043530 followed by a unit qualifier and the quantity

Package 46708-0435-30. 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 Jan 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Symptomatic Trichomoniasis . Metronidazole capsules USP 375 mg 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 capsules USP 375 mg 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 eradicatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079065

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

FDA NDC Directory listings under ANDA 079065
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 375 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-018