Pemetrexed
- Product NDC
- 71288-146
- 11-digit product format
- 712880146
- Labeler code
- 71288
- Product ID
- 71288-146_b369ac27-0118-4e53-be05-c9ba2dbf6875
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pemetrexed disodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA215479
- Marketing category
- ANDA
- Marketing start
- 2022-12-13
- Substance
- PEMETREXED DISODIUM HEPTAHYDRATE
- Active strength
- 500 mg/20mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pemetrexed
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMETREXED DISODIUM HEPTAHYDRATE | 500 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9T47E4OM16 |
| Rxcui | 1728072, 1728077, 2601728, 2602136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-146-50 | Pemetrexed | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 71288-146-50 | Pemetrexed | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-146 | PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221223_b185f459-5489-4e18-8521-1686b5d16f67.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 |
|---|
| 71288-146-50 | 71288014650 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-146-50) / 20 mL in 1 VIAL, SINGLE-DOSE | 2022-12-13 | 0000-00-00 | No | No | Current |