Fluorouracil
- Product NDC
- 21922-041
- 11-digit product format
- 219220041
- Labeler code
- 21922
- Product ID
- 21922-041_f42c30f3-a83e-4721-8aa1-50d56cb13f4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA215612
- Marketing category
- ANDA
- Marketing start
- 2023-11-06
- Substance
- FLUOROURACIL
- Active strength
- 50 mg/mL
- 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 | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 310380 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-041-12 | Fluorouracil | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 21922-041-12 | Fluorouracil | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-041 | FLUOROURACIL SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] | 3 | Current NDC, 2 package rows | 20231202_2c631ce7-ea15-4b51-b5bc-4962e3c315cd.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 |
|---|
| 21922-041-12 | 21922004112 | 1 BOTTLE in 1 CARTON (21922-041-12) / 10 mL in 1 BOTTLE | 1 bottle | 2023-11-06 | No | No | Current |