cytarabine
- Product NDC
- 25021-223
- 11-digit product format
- 250210223
- Labeler code
- 25021
- Product ID
- 25021-223_90be6aab-dfa3-4d2f-9dcb-cc1858f7c67e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cytarabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA211938
- Marketing category
- ANDA
- Marketing start
- 2023-06-01
- Substance
- CYTARABINE
- Active strength
- 100 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
- cytarabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYTARABINE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04079A1RDZ |
| Rxcui | 249364 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-223-20 | cytarabine | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 3 |
| 25021-223-20 | cytarabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-223 | CYTARABINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 3 | Current NDC, 2 package rows | 20230602_9bc7f6c2-4b16-449b-b383-76106540206c.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 |
|---|
| 25021-223-20 | 25021022320 | 1 VIAL in 1 CARTON (25021-223-20) / 20 mL in 1 VIAL | 1 vial | 2023-06-01 | No | No | Current |