What is NDC 0713-0575?

0713-0575 is the product NDC for Metronidazole, Metronidazole 7.5 mg/g gel, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 0713-0575 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0575Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0575Add 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
0713-0575-71	0071305757100713057571	1 TUBE, WITH APPLICATOR in 1 CARTON (0713-0575-71) / 70 g in 1 TUBE, WITH APPLICATORMarketed from Jul 12, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 7.5 mg/g
Dosage form: Gel
Route: Vaginal
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216323
Marketing start: Jul 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 0713-0575_00beeda9-9cf9-730b-e063-6294a90a8ad0SPL ID 00beeda9-9cf9-730b-e063-6294a90a8ad0SPL set ID d76810d5-11b4-4b5e-b850-230f59376c34RxCUI 142046UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400713057571 followed by a unit qualifier and the quantity

Package 00713-0575-71. 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 Jul 18, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginaldischarge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains cluecells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0575

What is NDC 0713-0575?: 0713-0575 is the product NDC for Metronidazole, Metronidazole 7.5 mg/g gel, listed with the FDA by Cosette 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?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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