FLUOROURACIL
- Product NDC
- 21922-049
- 11-digit product format
- 219220049
- Labeler code
- 21922
- Product ID
- 21922-049_f33d88a4-f57f-45c7-8c13-94d69e4d7931
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA216942
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- Substance
- FLUOROURACIL
- Active strength
- 2 g/40g
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUOROURACIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROURACIL | 2 g/40g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 105583 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-049-17 | FLUOROURACIL | 1 in 1 CARTON | CREAM | 1 | | 3 |
| 21922-049-17 | FLUOROURACIL | 40 g in 1 TUBE | CREAM | 40 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-049 | FLUOROURACIL CREAM [ENCUBE ETHICALS PRIVATE LIMITED] | 2 | Current NDC, 2 package rows | 20250215_30294dd2-40fb-420d-b838-376343308895.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 |
|---|
| 21922-049-17 | 21922004917 | 1 TUBE in 1 CARTON (21922-049-17) / 40 g in 1 TUBE | 1 tube | 2025-02-14 | No | No | Current |