Prescription drug · ANDA
grisofulvin NDC 69097-361
Griseofulvin 125 mg/5mL · Suspension · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-361-08 | 69097036108 | 120 mL in 1 BOTTLE (69097-361-08)Marketed from Mar 6, 2017 |
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)
- grisofulvin
- Generic name (nonproprietary)
- grisofulvin
- Active ingredients
- Griseofulvin — 125 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065354
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654SPL ID 6cf78fd3-5be6-412c-acdf-f599efaf0654SPL set ID d5c737e5-51b8-4322-a2a5-4d4a392c1f56RxCUI 239238UNII 32HRV3E3D5UPC 0369097361082
- 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
N469097036108followed by a unit qualifier and the quantityPackage 69097-0361-08. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Griseofulvin oral suspension 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 crateriformis Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte sho…
Excerpt only. Read the full label for complete information.