What is NDC 63187-035?

63187-035 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metronidazole?

160 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metronidazole NDC 63187-035 | National Drug Code

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	6318700350463187003504	4 TABLET in 1 BOTTLE (63187-035-04)Marketed from Dec 14, 2021
63187-035-14	6318700351463187003514	14 TABLET in 1 BOTTLE (63187-035-14)Marketed from Nov 1, 2018
63187-035-21	6318700352163187003521	21 TABLET in 1 BOTTLE (63187-035-21)Marketed from Nov 1, 2018
63187-035-28	6318700352863187003528	28 TABLET in 1 BOTTLE (63187-035-28)Marketed from Aug 23, 2024
63187-035-30	6318700353063187003530	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 LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070033
Marketing start: Sep 30, 1990
Listing expires: Dec 31, 2027
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)

About NDC 63187-035

What is NDC 63187-035?: 63187-035 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metronidazole.
What is the active ingredient?: Metronidazole.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metronidazole?: 160 other product NDCs are listed under this name. See all Metronidazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metronidazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4767	70518-4767-00
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Kanchan Healthcare Inc	85742-024	85742-0024-2485742-0024-25
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Kanchan Healthcare Inc	85742-025	85742-0025-2485742-0025-25
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2677	72162-2677-0172162-2677-0272162-2677-05
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2678	72162-2678-0172162-2678-0272162-2678-05
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1060	67046-1060-03
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1173	67046-1173-03
Metronidazole	Metronidazole 7.5 mg/g	GelTopical	Zydus Lifesciences Limited	70771-1978	70771-1978-04
Metronidazole	Metronidazole 7.5 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-209	72578-0209-04
Metronidazole	Metronidazole 7.5 mg/g	GelVaginal	Solaris Pharma Corporation	73473-303	73473-0303-70

All 161 Metronidazole NDCs

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	Teva Pharmaceuticals USA, Inc.	50111-334
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	REMEDYREPACK INC.	70518-1240
Metronidazole	Metronidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-1241