Pemetrexed
- Product NDC
- 63759-3050
- 11-digit product format
- 637593050
- Labeler code
- 63759
- Product ID
- 63759-3050_b0e3847a-fdcf-405c-823c-180fa8dad9c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pemetrexed disodium
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Shilpa Medicare Limited
- Application
- NDA215179
- Marketing category
- NDA
- Marketing start
- 2024-01-01
- Substance
- PEMETREXED DISODIUM HEMIPENTAHYDRATE
- Active strength
- 1000 mg/100mL
- 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 |
|---|---|
| PEMETREXED DISODIUM HEMIPENTAHYDRATE | 1000 mg/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F4GSH45R4C |
| Rxcui | 2637958, 2637966, 2637968 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6b7ab8f1-bb38-4c30-8b8b-003c0fe639ea | Product name | 1 | 20250303 |
| 0976ea44-ea26-403d-a39d-71fffc6a3d33 | Product name | 4 | 20250225 |
| f15e8921-7cd5-4c00-9cde-9fa0c9eaca68 | Product name | 1 | 20231013 |
| 0bb393b5-af67-4798-84a7-b797956b02a5 | Product name | 1 | 20230830 |
| 7ea5dc07-b4d4-439d-8145-a10a534148e7 | Product name | 1 | 20230320 |
| a620f3f0-1e13-41d6-a838-d5407971d39e | Product name | 1 | 20230313 |
| 8766e415-735a-4d2c-b173-894ecced3fd9 | Product name | 1 | 20230308 |
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63759-3050-1 | Pemetrexed | 100 mL in 1 VIAL | INJECTION | 100 | 8 | |
| 63759-3050-1 | Pemetrexed | 1 in 1 CARTON | INJECTION | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63759-3050 | PEMETREXED (PEMETREXED DISODIUM) INJECTION [SHILPA MEDICARE LIMITED] | 8 | Current NDC, 2 package rows | 20241205_fe432994-e61b-4a87-8c98-cc20b847d0fe.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637958 | PEMEtrexed 100 MG in 10 ML Injection | PSN | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637966 | PEMEtrexed 1000 MG in 100 ML Injection | PSN | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637968 | PEMEtrexed 500 MG in 50 ML Injection | PSN | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637958 | 10 ML pemetrexed 10 MG/ML Injection | SCD | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637966 | 100 ML pemetrexed 10 MG/ML Injection | SCD | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637968 | 50 ML pemetrexed 10 MG/ML Injection | SCD | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637958 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 10 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637966 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 100 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637968 | pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 50 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637958 | pemetrexed (as disodium hemipentahydrate) 100 MG per 10 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637966 | pemetrexed (as disodium hemipentahydrate) 1000 MG per 100 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
| 2637968 | pemetrexed (as disodium hemipentahydrate) 500 MG per 50 ML Injection | SY | fe432994-e61b-4a87-8c98-cc20b847d0fe | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63759-3050-1 | 63759305001 | 1 VIAL in 1 CARTON (63759-3050-1) / 100 mL in 1 VIAL | 1 vial | 2024-01-01 | No | No | Current |