Prescription drug · ANDA
Griseofulvin NDC 0472-0013
Griseofulvin 125 mg/5mL · Suspension · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0472-0013-04 | 0047200130400472001304 | 120 mL in 1 BOTTLE (0472-0013-04)Marketed from Jul 26, 2007 |
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 — 125 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0472
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065394
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Mitosis (Physiologic effect)Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 0472-0013_ffdfb856-e4f1-41de-837b-a773b1f6eaf9SPL ID ffdfb856-e4f1-41de-837b-a773b1f6eaf9SPL set ID af318d5d-cc39-4a63-a590-b87c50f2694fRxCUI 239238UNII 32HRV3E3D5
- 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
N400472001304followed by a unit qualifier and the quantityPackage 00472-0013-04. 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, USP 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 …
Excerpt only. Read the full label for complete information.
About NDC 0472-0013
- What is NDC 0472-0013?
- 0472-0013 is the product NDC for Griseofulvin, Griseofulvin 125 mg/5mL suspension, listed with the FDA by Actavis Pharma, Inc.. 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?
- Actavis Pharma, Inc., NDC labeler code 0472. 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 | Sandoz Inc | 0781-5515 | 00781-5515-0100781-5515-05 |
| Griseofulvin | Griseofulvin 500 mg/1 | TabletOral | Sigmapharm Laboratories, LLC | 42794-012 | 42794-0012-08 |
| Griseofulvingriseofulvin (microsize) | Griseofulvin 125 mg/5mL | SuspensionOral | Chartwell RX, LLC. | 62135-968 | 62135-0968-41 |