PEMRYDI RTU
- Product NDC
- 70121-2453
- 11-digit product format
- 701212453
- Labeler code
- 70121
- Product ID
- 70121-2453_b6a00be1-95d1-4b91-93bf-4430a57eeff6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pemetrexed disodium
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA215179
- Marketing category
- NDA
- Marketing start
- 2023-06-06
- Substance
- PEMETREXED DISODIUM HEMIPENTAHYDRATE
- Active strength
- 100 mg/10mL
- 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 |
|---|
| N215179-001 | PEMETREXED | PEMETREXED DISODIUM | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | | RLD, RS | 2023-05-22 |
| N215179-002 | PEMETREXED | PEMETREXED DISODIUM | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | | RLD, RS | 2023-05-22 |
| N215179-003 | PEMETREXED | PEMETREXED DISODIUM | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | | RLD, RS | 2023-05-22 |
Orange Book patents#
Application-product, Patent, Expiration table| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|
| N215179-001 | 11147817 | 2035-03-26 | | Drug product | 2023-06-06 |
| N215179-002 | 11147817 | 2035-03-26 | | Drug product | 2023-06-06 |
| N215179-003 | 11147817 | 2035-03-26 | | Drug product | 2023-06-06 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PEMRYDI RTU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMETREXED DISODIUM HEMIPENTAHYDRATE | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F4GSH45R4C |
| Rxcui | 2637958, 2637964, 2637966, 2637967, 2637968, 2637969 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-2453-1 | PEMRYDI RTU | 10 mL in 1 VIAL | INJECTION | 10 | | 8 |
| 70121-2453-1 | PEMRYDI RTU | 1 in 1 CARTON | INJECTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-2453 | PEMRYDI RTU (PEMETREXED DISODIUM) INJECTION [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, 2 package rows | 20241212_0f006b06-ab85-423d-ba0c-dfc3fc25844e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2453-1 | 70121245301 | 1 VIAL in 1 CARTON (70121-2453-1) / 10 mL in 1 VIAL | 1 vial | 2023-06-06 | No | No | Current |