Cytarabine
- Product NDC
- 68083-337
- 11-digit product format
- 680830337
- Labeler code
- 68083
- Product ID
- 68083-337_b913ae17-4b11-4748-a883-eba1bc9e9c06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cytarabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA211938
- Marketing category
- ANDA
- Marketing start
- 2019-12-23
- 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 |
|---|
| 68083-337-01 | Cytarabine | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 4 |
| 68083-337-01 | 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 |
|---|
| 68083-337 | CYTARABINE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200715_cb0db038-4a65-42c7-aa79-5c88309061df.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 |
|---|
| 68083-337-01 | 68083033701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-337-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2019-12-23 | 0000-00-00 | No | No | Current |