What is NDC 63629-1386?

63629-1386 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-1386 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-1386Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-1386Add 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
63629-1386-0	6362913860063629138600	40 TABLET in 1 BOTTLE (63629-1386-0)Marketed from Aug 3, 2010
63629-1386-1	6362913860163629138601	20 TABLET in 1 BOTTLE (63629-1386-1)Marketed from Dec 16, 2004
63629-1386-2	6362913860263629138602	30 TABLET in 1 BOTTLE (63629-1386-2)Marketed from Dec 20, 2004
63629-1386-3	6362913860363629138603	14 TABLET in 1 BOTTLE (63629-1386-3)Marketed from Mar 26, 2007
63629-1386-4	6362913860463629138604	56 TABLET in 1 BOTTLE (63629-1386-4)Marketed from Aug 10, 2006
63629-1386-5	6362913860563629138605	21 TABLET in 1 BOTTLE (63629-1386-5)Marketed from Feb 12, 2009
63629-1386-6	6362913860663629138606	4 TABLET in 1 BOTTLE (63629-1386-6)Marketed from Jun 12, 2008
63629-1386-7	6362913860763629138607	28 TABLET in 1 BOTTLE (63629-1386-7)Marketed from Jul 7, 2008
63629-1386-8	6362913860863629138608	100 TABLET in 1 BOTTLE (63629-1386-8)Marketed from Aug 26, 2010
63629-1386-9	6362913860963629138609	60 TABLET in 1 BOTTLE (63629-1386-9)Marketed from Mar 8, 2022

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
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 63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27caSPL ID 7a0f2236-cf51-409f-94f9-ce62135b27caSPL set ID e1e7e127-e99e-80e9-1606-71261658b0c1RxCUI 311681UNII 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 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

N463629138600 followed by a unit qualifier and the quantity

Package 63629-1386-00. 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 Nov 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Symptomatic Trichomoniasis Metronidazole tablets 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 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. Treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1386

What is NDC 63629-1386?: 63629-1386 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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	Proficient Rx LP	63187-035
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