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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PEMRYDI RTU
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEMETREXED DISODIUM HEMIPENTAHYDRATE | 100 mg/10mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F4GSH45R4C |
| Rxcui | 2637958, 2637964, 2637966, 2637967, 2637968, 2637969 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-2453-1 | ML - Milliliter | 70121-2453 | b2742aa7-a5ec-4483-9ed2-11bb5442cd4a | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| 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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637958 | PEMEtrexed 100 MG in 10 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637966 | PEMEtrexed 1000 MG in 100 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637968 | PEMEtrexed 500 MG in 50 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637964 | PEMRYDI RTU 100 MG in 10 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637967 | PEMRYDI RTU 1000 MG in 100 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637969 | PEMRYDI RTU 500 MG in 50 ML Injection | PSN | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637964 | 10 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu] | SBD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637967 | 100 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu] | SBD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637969 | 50 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu] | SBD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637958 | 10 ML pemetrexed 10 MG/ML Injection | SCD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637966 | 100 ML pemetrexed 10 MG/ML Injection | SCD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637968 | 50 ML pemetrexed 10 MG/ML Injection | SCD | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637958 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 10 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637966 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 100 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637968 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 50 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637958 | pemetrexed (as disodium hemipentahydrate) 100 MG per 10 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637966 | pemetrexed (as disodium hemipentahydrate) 1000 MG per 100 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637968 | pemetrexed (as disodium hemipentahydrate) 500 MG per 50 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637964 | Pemrydi Rtu 10 MG/ML per 10 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637967 | Pemrydi Rtu 10 MG/ML per 100 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637969 | Pemrydi Rtu 10 MG/ML per 50 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637964 | Pemrydi Rtu 100 MG per 10 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637967 | Pemrydi Rtu 1000 MG per 100 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
| 2637969 | Pemrydi Rtu 500 MG per 50 ML Injection | SY | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 8 |
Packages#
| 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 |