Fluorouracil
- Product NDC
- 71288-170
- 11-digit product format
- 712880170
- Labeler code
- 71288
- Product ID
- 71288-170_cb5958dc-12bd-4172-b45e-34b591eb316c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA216494
- Marketing category
- ANDA
- Marketing start
- 2024-09-24
- 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 |
|---|
| 71288-170-75 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | | 11 |
| 71288-170-75 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-170 | FLUOROURACIL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 8 | Current NDC, 2 package rows | 20241004_a0cd6301-c6e0-4b62-8683-39c99913db24.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-170-75 | 71288017075 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2024-09-24 | No | No | Current |