Metronidazole NDC 63187-035

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0035Add 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
63187-035-04	63187003504	4 TABLET in 1 BOTTLE (63187-035-04)Marketed from Dec 14, 2021
63187-035-14	63187003514	14 TABLET in 1 BOTTLE (63187-035-14)Marketed from Nov 1, 2018
63187-035-21	63187003521	21 TABLET in 1 BOTTLE (63187-035-21)Marketed from Nov 1, 2018
63187-035-28	63187003528	28 TABLET in 1 BOTTLE (63187-035-28)Marketed from Aug 23, 2024
63187-035-30	63187003530	30 TABLET in 1 BOTTLE (63187-035-30)Marketed from Nov 1, 2018

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070033
Marketing start: Sep 30, 1990
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252SPL ID b8ba0cbc-99a5-485f-ae3f-85a2b342c252SPL set ID e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205RxCUI 311681UNII 140QMO216EUPC 0363187035044
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

N463187003504 followed by a unit qualifier and the quantity

Package 63187-0035-04. 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 Aug 1, 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. T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 070033

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

FDA NDC Directory listings under ANDA 070033
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-1240
Metronidazole	Metronidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-1241
Metronidazole	Metronidazole 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-1386
Metronidazole	Metronidazole 500 mg/1	TabletOral	Redpharm Drug, inc.	67296-0078
Metronidazole	Metronidazole 500 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	50111-334