What is NDC 0713-0850?

0713-0850 is the product NDC for Griseofulvin, Griseofulvin 125 mg/5mL suspension, 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 Griseofulvin?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Griseofulvin NDC 0713-0850 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0850Add 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
0713-0850-04	0071308500400713085004	118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)Marketed from Nov 1, 2022

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): Griseofulvin
Generic name (nonproprietary): griseofulvin
Active ingredients: Griseofulvin — 125 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065438
Marketing start: Nov 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 0713-0850_284eb653-b312-78e5-e063-6394a90a1e17SPL ID 284eb653-b312-78e5-e063-6394a90a1e17SPL set ID 67e3ba3c-77e1-43b5-a93c-5bf5e3855780RxCUI 239238UNII 32HRV3E3D5UPC 0307130850049
Pharmacologic class: Tubulin Inhibiting Agent

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

N400713085004 followed by a unit qualifier and the quantity

Package 00713-0850-04. 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 Dec 2, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should be identified …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0850

What is NDC 0713-0850?: 0713-0850 is the product NDC for Griseofulvin, Griseofulvin 125 mg/5mL suspension, 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?: Griseofulvin.
What is the active ingredient?: Griseofulvin.
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 Griseofulvin?: 5 other product NDCs are listed under this name. See all Griseofulvin 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 Griseofulvin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Griseofulvin	Griseofulvin 250 mg/1	TabletOral	Sandoz Inc	0781-5514	00781-5514-0100781-5514-05
Griseofulvin	Griseofulvin 500 mg/1	TabletOral	Sandoz Inc	0781-5515	00781-5515-0100781-5515-05
Griseofulvin	Griseofulvin 500 mg/1	TabletOral	Sigmapharm Laboratories, LLC	42794-012	42794-0012-08
Griseofulvin	Griseofulvin 125 mg/5mL	SuspensionOral	Actavis Pharma, Inc.	0472-0013	00472-0013-04
Griseofulvingriseofulvin (microsize)	Griseofulvin 125 mg/5mL	SuspensionOral	Chartwell RX, LLC.	62135-968	62135-0968-41