Pemetrexed
- Product NDC
- 63323-134
- 11-digit product format
- 633230134
- Labeler code
- 63323
- Product ID
- 63323-134_c7ff62a1-e697-4a7c-9907-59163f393528
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PEMETREXED DISODIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA090384
- Marketing category
- ANDA
- Marketing start
- 2022-05-25
- Substance
- PEMETREXED DISODIUM
- Active strength
- 100 mg/4mL
- 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 | 100 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2PKU919BA9 |
| 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 |
|---|
| 63323-134-10 | Pemetrexed | 4 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 4 | | 10 |
| 63323-134-10 | Pemetrexed | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-134 | PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240112_ae77f00f-d43b-4b75-afd5-a2a9cb7138da.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 |
|---|
| 63323-134-10 | 63323013410 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE | 2022-05-25 | 0000-00-00 | No | No | Current |