What is NDC 63629-1388?

63629-1388 is the product NDC for Metronidazole, Metronidazole 250 mg/1 tablet, film coated, 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 63629-1388 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-1388Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-1388Add 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
63629-1388-0	6362913880063629138800	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-0)Marketed from Sep 14, 2017
63629-1388-1	6362913880163629138801	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-1)Marketed from Sep 4, 2024
63629-1388-2	6362913880263629138802	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-2)Marketed from Sep 4, 2024
63629-1388-3	6362913880363629138803	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-3)Marketed from Sep 4, 2024
63629-1388-4	6362913880463629138804	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-4)Marketed from Sep 4, 2024
63629-1388-5	6362913880563629138805	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-5)Marketed from Sep 4, 2024
63629-1388-6	6362913880663629138806	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-6)Marketed from Sep 4, 2024
63629-1388-7	6362913880763629138807	40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-7)Marketed from Sep 4, 2024
63629-1388-8	6362913880863629138808	42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-8)Marketed from Mar 6, 2018
63629-1388-9	6362913880963629138809	56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-9)Marketed from Sep 4, 2024

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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203458
Marketing start: Jun 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8SPL ID e2a4bade-0163-4eed-8887-2fa27de3e0b8SPL set ID 8e1f507b-22fa-4033-9b3e-5435f20ace66RxCUI 314106UNII 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

N463629138800 followed by a unit qualifier and the quantity

Package 63629-1388-00. 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 Sep 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. Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1388

What is NDC 63629-1388?: 63629-1388 is the product NDC for Metronidazole, Metronidazole 250 mg/1 tablet, film coated, 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 203458

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

FDA NDC Directory listings under ANDA 203458
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-226
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-227
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-1876
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-6960
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3039
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2403
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2152
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Direct_Rx	61919-032
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2305
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4767
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-719
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2280
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2640
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0358
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	PharmPak, Inc.	54348-740
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	PharmPak, Inc.	54348-745
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0213
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0201
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0211
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0212

Showing 20 of 33.