Griseofulvin
- Product NDC
- 0713-0850
- 11-digit product format
- 007130850
- Labeler code
- 0713
- Product ID
- 0713-0850_284eb653-b312-78e5-e063-6394a90a1e17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Griseofulvin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA065438
- Marketing category
- ANDA
- Marketing start
- 2022-11-01
- Substance
- GRISEOFULVIN
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Griseofulvin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GRISEOFULVIN | 125 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 32HRV3E3D5 |
| Rxcui | 239238 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0850-04 | Griseofulvin | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0850 | GRISEOFULVIN SUSPENSION [COSETTE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241204_67e3ba3c-77e1-43b5-a93c-5bf5e3855780.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0713-0850-04 | 00713085004 | 118 mL in 1 BOTTLE, PLASTIC (0713-0850-04) | 118 ml | 2022-11-01 | 0000-00-00 | No | No | Current |