What is NDC 68071-5283?

68071-5283 is the product NDC for Metronidazole, Metronidazole 250 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 68071-5283 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-5283Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-5283Add 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	Copy
68071-5283-8	6807152830868071528308	28 TABLET in 1 BOTTLE, PLASTIC (68071-5283-8)Marketed from Jun 18, 2020

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
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205245
Marketing start: Nov 29, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 68071-5283_2a307d1e-9ca1-c34a-e063-6294a90af55cSPL ID 2a307d1e-9ca1-c34a-e063-6294a90af55cSPL set ID a860b097-7447-a3b7-e053-2995a90a4bfdRxCUI 314106UNII 140QMO216EUPC 0368071528381
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

N468071528308 followed by a unit qualifier and the quantity

Package 68071-5283-08. 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 Dec 26, 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. Treatm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-5283

What is NDC 68071-5283?: 68071-5283 is the product NDC for Metronidazole, Metronidazole 250 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 205245

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

FDA NDC Directory listings under ANDA 205245
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 500 mg/1	TabletOral	Major Pharmaceuticals	0904-7126
Metronidazole	Metronidazole 250 mg/1	TabletOral	Major Pharmaceuticals	0904-7156
Metronidazole	Metronidazole 250 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-651
Metronidazole	Metronidazole 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-652
Metronidazole	Metronidazole 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-441
Metronidazole	Metronidazole 250 mg/1	TabletOral	Northwind Health Company, LLC	51655-974
Metronidazole	Metronidazole 250 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2343
Metronidazole	Metronidazole 250 mg/1	TabletOral	Chartwell RX, LLC	62135-795
Metronidazole	Metronidazole 500 mg/1	TabletOral	Chartwell RX, LLC	62135-796
Metronidazole	Metronidazole 250 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2251
Metronidazole	Metronidazole 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-3265