Cytarabine
- Product NDC
- 63323-120
- 11-digit product format
- 633230120
- Labeler code
- 63323
- Product ID
- 63323-120_88adbc49-b19d-44af-8f0b-a563bbb02aec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYTARABINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076512
- Marketing category
- ANDA
- Marketing start
- 2004-11-29
- 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 |
|---|
| 63323-120-20 | Cytarabine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63323-120-20 | Cytarabine | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYTARABINE | ACTIVE INGREDIENT | 04079A1RDZ | CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| CYTARABINE | ACTIVE MOIETY | 04079A1RDZ | CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-120 | CYTARABINE (CYTARABINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210710_c4fdc56e-efd7-4825-a518-ef430b2b3df0.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 |
|---|
| 63323-120-20 | 63323012020 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2004-11-29 | 0000-00-00 | No | No | Current |