Podofilox
- Product NDC
- 0574-0621
- 11-digit product format
- 005740621
- Labeler code
- 0574
- Product ID
- 0574-0621_d2e70c5e-d4a9-4295-9eff-517ffb974e61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Podofilox
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis US LLC
- Application
- ANDA211871
- Marketing category
- ANDA
- Marketing start
- 2023-12-13
- Substance
- PODOFILOX
- Active strength
- 5 mg/g
- Pharmacologic classes
- Decreased Mitosis [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Podofilox
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PODOFILOX | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L36H50F353 |
| Rxcui | 312466 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-0621-05 | Podofilox | 3.5 g in 1 TUBE, WITH APPLICATOR | GEL | 3.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0621 | PODOFILOX GEL [PADAGIS US LLC] | 2 | Current NDC, 1 package rows | 20231214_d2e70c5e-d4a9-4295-9eff-517ffb974e61.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0574-0621-05 | 00574062105 | 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05) | 3.5 g | 2023-12-13 | No | No | Current |