Prescription drug · ANDA
Griseofulvin NDC 0781-5515
Griseofulvin 500 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5515-01 | 0078155150100781551501 | 100 TABLET in 1 BOTTLE (0781-5515-01)Marketed from Aug 7, 2013 | |
| 0781-5515-05 | 0078155150500781551505 | 500 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
N400781551501followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Griseofulvin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |
Other NDCs under ANDA 091592
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Griseofulvin | Griseofulvin 250 mg/1 | TabletOral | Sandoz Inc | 0781-5514 |