Cytarabine
- Product NDC
- 71288-169
- 11-digit product format
- 712880169
- Labeler code
- 71288
- Product ID
- 71288-169_bb497b35-a3a3-43e8-a187-6ad2851acf26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cytarabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA208485
- Marketing category
- ANDA
- Marketing start
- 2022-02-28
- Substance
- CYTARABINE
- Active strength
- 20 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04079A1RDZ |
| Rxcui | 240416 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-169-25 | Cytarabine | 25 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 25 | | 4 |
| 71288-169-25 | Cytarabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-169 | CYTARABINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221130_8b366382-c8d1-4344-86b7-f65e92a8952b.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 |
|---|
| 71288-169-25 | 71288016925 | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-169-25) / 25 mL in 1 VIAL, MULTI-DOSE | 2022-02-28 | 0000-00-00 | No | No | Current |