Fluorouracil
- Product NDC
- 71288-154
- 11-digit product format
- 712880154
- Labeler code
- 71288
- Product ID
- 71288-154_0097ac5b-1a37-46b0-8e5b-d8ae2311a25d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA215699
- Marketing category
- ANDA
- Marketing start
- 2025-02-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluorouracil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROURACIL | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 239177 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-154-76 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 71288-154-76 | Fluorouracil | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-154 | FLUOROURACIL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20250216_de8a3fce-85a9-4a77-a3cd-e50179b93098.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-154-76 | 71288015476 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-154-76) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-02-06 | No | No | Current |