Fluorouracil
- Product NDC
- 68083-270
- 11-digit product format
- 680830270
- Labeler code
- 68083
- Product ID
- 68083-270_0e5faa31-6fd8-49b5-b838-1278cf068666
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA210123
- Marketing category
- ANDA
- Marketing start
- 2017-11-07
- 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 | 1791701, 1791736 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-270-01 | Fluorouracil | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 8 |
| 68083-270-10 | Fluorouracil | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-270 | FLUOROURACIL INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240229_572b710e-8e2b-46eb-bd80-648ad769d34d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-270-01 | 68083027001 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 68083-270-10 | 68083027010 | 10 VIAL in 1 CARTON (68083-270-10) / 20 mL in 1 VIAL (68083-270-01) | 10 vial | 2017-11-07 | 0000-00-00 | No | No | Current |