| Product NDC: | 0009-3359 |
| Proprietary Name: | Prepidil |
| Non Proprietary Name: | dinoprostone |
| Active Ingredient(s): | .5 mg/3g & nbsp; dinoprostone |
| Administration Route(s): | VAGINAL |
| Dosage Form(s): | GEL |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0009-3359 |
| Labeler Name: | Pharmacia and Upjohn Company |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019617 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19921209 |
| Package NDC: | 0009-3359-02 |
| Package Description: | 5 SYRINGE in 1 PACKAGE (0009-3359-02) > 3 g in 1 SYRINGE |
| NDC Code | 0009-3359-02 |
| Proprietary Name | Prepidil |
| Package Description | 5 SYRINGE in 1 PACKAGE (0009-3359-02) > 3 g in 1 SYRINGE |
| Product NDC | 0009-3359 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | dinoprostone |
| Dosage Form Name | GEL |
| Route Name | VAGINAL |
| Start Marketing Date | 19921209 |
| Marketing Category Name | NDA |
| Labeler Name | Pharmacia and Upjohn Company |
| Substance Name | DINOPROSTONE |
| Strength Number | .5 |
| Strength Unit | mg/3g |
| Pharmaceutical Classes | Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] |