Pralatrexate
- Product NDC
- 65219-552
- 11-digit product format
- 652190552
- Labeler code
- 65219
- Product ID
- 65219-552_510bc71b-20e4-428a-8fc2-29c9fc20f2f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pralatrexate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA022468
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-11-15
- Substance
- PRALATREXATE
- Active strength
- 40 mg/2mL
- Pharmacologic classes
- Folate Analog 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
- Pralatrexate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRALATREXATE | 40 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A8Q8I19Q20 |
| Rxcui | 1796419, 1796424 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-552-02 | Pralatrexate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 1 |
| 65219-552-02 | Pralatrexate | 1 in 1 CARTON | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-552 | PRALATREXATE INJECTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221119_a5daa583-4965-4564-ad87-41ffe6c08a11.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 |
|---|
| 65219-552-02 | 65219055202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-15 | 0000-00-00 | No | No | Current |