Prescription drug · ANDA
Griseofulvin NDC 0781-5514
Griseofulvin 250 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5514-01 | 00781551401 | 100 TABLET in 1 BOTTLE (0781-5514-01)Marketed from Aug 7, 2013 | |
| 0781-5514-05 | 00781551405 | 500 TABLET in 1 BOTTLE (0781-5514-05)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 — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz Inc
- 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 0781-5514_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
N400781551401followed by a unit qualifier and the quantityPackage 00781-5514-01. 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.
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 500 mg/1 | TabletOral | Sandoz Inc | 0781-5515 |