| Product NDC: | 64011-243 |
| Proprietary Name: | Makena |
| Non Proprietary Name: | Hydroxyprogesterone Caproate |
| Active Ingredient(s): | 250 mg/mL & nbsp; Hydroxyprogesterone Caproate |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 64011-243 |
| Labeler Name: | Ther-Rx Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021945 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110203 |
| Package NDC: | 64011-243-01 |
| Package Description: | 1 VIAL, GLASS in 1 CARTON (64011-243-01) > 5 mL in 1 VIAL, GLASS |
| NDC Code | 64011-243-01 |
| Proprietary Name | Makena |
| Package Description | 1 VIAL, GLASS in 1 CARTON (64011-243-01) > 5 mL in 1 VIAL, GLASS |
| Product NDC | 64011-243 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydroxyprogesterone Caproate |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20110203 |
| Marketing Category Name | NDA |
| Labeler Name | Ther-Rx Corporation |
| Substance Name | HYDROXYPROGESTERONE CAPROATE |
| Strength Number | 250 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |