Folotyn
- Product NDC
- 48818-001
- 11-digit product format
- 488180001
- Labeler code
- 48818
- Product ID
- 48818-001_dc6e58a9-4f26-460b-b387-41e524d3f9a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pralatrexate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Acrotech Biopharma LLC
- Application
- NDA022468
- Marketing category
- NDA
- Marketing start
- 2009-09-24
- Marketing end
- 0000-00-00
- Substance
- PRALATREXATE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 48818-001-01 | 2023-04-18 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-02 | 2023-04-18 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-02 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-01 | 2021-10-08 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-02 | 2021-10-08 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
| 48818-001-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2d8d-a910-e053-dadaa90a0b85 | 5e4cf15b-bf7b-4b83-863e-e9ef27741a51 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48818-001-01 | ML - Milliliter | 48818-001 | b1d0dd02-ec6b-47f7-acdb-42e56d067a7b | 1 | 2012-07-24 |
| 48818-001-02 | ML - Milliliter | 48818-001 | c8636418-6888-4641-b710-4b50c3fa231f | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48818-001-01 | 48818000101 | 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE | 2009-09-24 | 2023-06-30 | No | No | Current |
| 48818-001-02 | 48818000102 | 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-02) > 2 mL in 1 VIAL, SINGLE-USE | 2009-09-24 | 2024-02-29 | No | No | Current |