Pralatrexate
- Product NDC
- 43598-343
- 11-digit product format
- 435980343
- Labeler code
- 43598
- Product ID
- 43598-343_b885a7b3-a241-638d-8f27-d162c562469a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pralatrexate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Dr.Reddy's Laboratories Inc.,
- Application
- ANDA206183
- Marketing category
- ANDA
- Marketing start
- 2026-03-04
- Substance
- PRALATREXATE
- Active strength
- 40 mg/2mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pralatrexate
- Listing expiration
- 2027-12-31
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 |
|---|
| 43598-343-23 | Pralatrexate | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 43598-343-23 | Pralatrexate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-343-23 | 43598034323 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-343-23) / 2 mL in 1 VIAL, SINGLE-DOSE | 2026-03-04 | No | No | Historical |