Fluorouracil
- Product NDC
- 68083-292
- 11-digit product format
- 680830292
- Labeler code
- 68083
- Product ID
- 68083-292_4680580c-772c-490d-bde9-c506c961e0b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA210124
- Marketing category
- ANDA
- Marketing start
- 2018-01-05
- 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 |
|---|
| 68083-292-01 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | | 7 |
| 68083-292-01 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-292 | FLUOROURACIL INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240229_ea3497db-23b9-4ace-9a6f-b54853d04a82.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 |
|---|
| 68083-292-01 | 68083029201 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-292-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2018-01-05 | 0000-00-00 | No | No | Current |