Fluorouracil
- Product NDC
- 62332-751
- 11-digit product format
- 623320751
- Labeler code
- 62332
- Product ID
- 62332-751_877caa50-ffd0-4c33-b61d-676c0b6ec82a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA217295
- Marketing category
- ANDA
- Marketing start
- 2023-03-03
- 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 | 239177 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-751-50 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | | 8 |
| 62332-751-50 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-751 | FLUOROURACIL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.] | 7 | Current NDC, 2 package rows | 20240503_6b34cbf2-66f9-48a4-b41f-deb84ba8e8c4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-751-50 | 62332075150 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (62332-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2023-03-03 | No | No | Historical |