pemetrexed
- Product NDC
- 70771-1691
- 11-digit product format
- 707711691
- Labeler code
- 70771
- Product ID
- 70771-1691_fc5f4aa1-92c4-444b-8e64-53708c9a67bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pemetrexed disodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214073
- Marketing category
- ANDA
- Marketing start
- 2022-05-26
- 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
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A214073-001 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
| A214073-002 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
| A214073-003 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
Therapeutic equivalence codes#
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1691-1 | pemetrexed | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 70771-1691-1 | pemetrexed | 4 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1691 | PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220527_6986de29-b077-48ac-ad2b-0cc478f72d89.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 |
|---|
| 70771-1691-1 | 70771169101 | 1 VIAL in 1 CARTON (70771-1691-1) / 4 mL in 1 VIAL | 1 vial | 2022-05-26 | 0000-00-00 | No | No | Current |