PEMETREXED
- Product NDC
- 16729-230
- 11-digit product format
- 167290230
- Labeler code
- 16729
- Product ID
- 16729-230_1d874430-c6ce-cff2-e063-6394a90a4a49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pemetrexed
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA203485
- Marketing category
- ANDA
- Marketing start
- 2022-05-25
- Substance
- PEMETREXED DISODIUM HEMIPENTAHYDRATE
- 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 HEMIPENTAHYDRATE | 500 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F4GSH45R4C |
| Rxcui | 1728072, 1728077, 2601728 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-230-11 | PEMETREXED | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 16729-230-11 | PEMETREXED | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-230 | PEMETREXED INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240719_dfd19e67-54cb-c062-e053-2995a90a294a.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 |
|---|
| 16729-230-11 | 16729023011 | 1 VIAL in 1 CARTON (16729-230-11) / 20 mL in 1 VIAL | 1 vial | 2022-05-25 | 0000-00-00 | No | No | Current |