FLUOROURACIL
- Product NDC
- 55150-496
- 11-digit product format
- 551500496
- Labeler code
- 55150
- Product ID
- 55150-496_7784c6bc-2624-42ba-a4ea-c63624eecec9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOROURACIL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA202668
- Marketing category
- ANDA
- Marketing start
- 2022-04-08
- 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 | 1791701, 1791736 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-496-01 | FLUOROURACIL | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 55150-496-10 | FLUOROURACIL | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-496 | FLUOROURACIL INJECTION, SOLUTION [EUGIA US LLC] | 3 | Current NDC, 2 package rows | 20240707_199ef964-8a9b-403e-a2ae-759280b3d1d1.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 |
|---|
| 55150-496-01 | 55150049601 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 55150-496-10 | 55150049610 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-496-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-496-01) | | 2022-04-08 | No | No | Historical |