NDC codes

FDA NDC Directory
Product NDC (as listed)0781-5515Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-5515Add 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 NDC11-digit (billing)PackageCopy
0781-5515-010078155150100781551501100 TABLET in 1 BOTTLE (0781-5515-01)Marketed from Aug 7, 2013
0781-5515-050078155150500781551505500 TABLET in 1 BOTTLE (0781-5515-05)Marketed from Aug 7, 2013

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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091592
Marketing start
Listing expires
Other FDA classes
Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
Identifiers
Product ID 0781-5515_79afc7a7-d77e-48eb-b1c6-6ea974801f38SPL ID 79afc7a7-d77e-48eb-b1c6-6ea974801f38SPL set ID 98829d90-b289-4bec-a625-7af412a5cb2dRxCUI 239239, 310600UNII 32HRV3E3D5UPC 0307815514013
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

N400781551501 followed by a unit qualifier and the quantity

Package 00781-5515-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Griseofulvin tablets, USP are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5515

What is NDC 0781-5515?
0781-5515 is the product NDC for Griseofulvin, Griseofulvin 500 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 2 package NDCs, 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?
Sandoz Inc, NDC labeler code 0781. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GriseofulvinGriseofulvin 125 mg/5mLSuspensionOralCosette Pharmaceuticals, Inc.0713-085000713-0850-04
GriseofulvinGriseofulvin 250 mg/1TabletOralSandoz Inc0781-551400781-5514-0100781-5514-05
GriseofulvinGriseofulvin 500 mg/1TabletOralSigmapharm Laboratories, LLC42794-01242794-0012-08
GriseofulvinGriseofulvin 125 mg/5mLSuspensionOralActavis Pharma, Inc.0472-001300472-0013-04
Griseofulvingriseofulvin (microsize)Griseofulvin 125 mg/5mLSuspensionOralChartwell RX, LLC.62135-96862135-0968-41

Other NDCs under ANDA 091592

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

FDA NDC Directory listings under ANDA 091592
ProductStrengthForm · routeLabelerProduct NDC
GriseofulvinGriseofulvin 250 mg/1TabletOralSandoz Inc0781-5514

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