Folotyn
- Product NDC
- 72893-005
- 11-digit product format
- 728930005
- Labeler code
- 72893
- Product ID
- 72893-005_08d15e08-706e-4f2c-af12-bee22e1b8251
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pralatrexate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Acrotech Biopharma Inc
- Application
- NDA022468
- Marketing category
- NDA
- Marketing start
- 2009-09-24
- 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
- Folotyn
- 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, 1796421, 1796424, 1796425 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72893-005-01 | Folotyn | 2 mL in 1 VIAL | INJECTION | 2 | | 9 |
| 72893-005-01 | Folotyn | 1 in 1 CARTON | INJECTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72893-005 | FOLOTYN (PRALATREXATE) INJECTION [ACROTECH BIOPHARMA INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240927_9f3d9c4d-9386-4451-b712-0fbdc5478d8f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72893-005-01 | 72893000501 | 1 VIAL in 1 CARTON (72893-005-01) / 2 mL in 1 VIAL | 1 vial | 2009-09-24 | 0000-00-00 | No | No | Current |