What is NDC 42794-012?

42794-012 is the product NDC for Griseofulvin, Griseofulvin 500 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sigmapharm Laboratories, LLC, NDC labeler code 42794. 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 42794-012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0012Add 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
42794-012-08	4279400120842794001208	30 TABLET in 1 BOTTLE (42794-012-08)Marketed from Jul 1, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sigmapharm Laboratories, LLCNDC labeler code 42794
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202482
Marketing start: Dec 6, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 42794-012_e8a91e6c-8bed-66f5-e053-2a95a90aa489SPL ID e8a91e6c-8bed-66f5-e053-2a95a90aa489SPL set ID 5bafb97f-621b-4b96-a787-68e0bb5c8637RxCUI 310600UNII 32HRV3E3D5UPC 0342794012082
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

N442794001208 followed by a unit qualifier and the quantity

Package 42794-0012-08. 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 Sep 14, 2022.

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 42794-012

What is NDC 42794-012?: 42794-012 is the product NDC for Griseofulvin, Griseofulvin 500 mg/1 tablet, listed with the FDA by Sigmapharm Laboratories, LLC. 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?: Sigmapharm Laboratories, LLC, NDC labeler code 42794. 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 125 mg/5mL	SuspensionOral	Cosette Pharmaceuticals, Inc.	0713-0850	00713-0850-04
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 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