Fluorouracil
- Product NDC
- 68001-525
- 11-digit product format
- 680010525
- Labeler code
- 68001
- Product ID
- 68001-525_4bbe6cbf-4510-e811-e063-6294a90a0e28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA210124
- Marketing category
- ANDA
- Marketing start
- 2022-02-18
- 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 |
|---|
| 68001-525-27 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 68001-525-27 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | | 5 |
| 68001-525-32 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 68001-525-32 | Fluorouracil | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-525 | FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250114_300304fa-4791-4455-962c-493ae467f504.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68001-525-27 | 68001052527 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-02-18 | 0000-00-00 | No | No | Current |
| 68001-525-32 | 68001052532 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-32) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-02-18 | 0000-00-00 | No | No | Current |