| NDC Code | 0378-3340-53 |
| Package Description | 3 POUCH in 1 CARTON (0378-3340-53) > 1 PATCH in 1 POUCH (0378-3340-16) > 7 d in 1 PATCH |
| Product NDC | 0378-3340 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Xulane |
| Non-Proprietary Name | Norelgestromin And Ethinyl Estradiol |
| Dosage Form | PATCH |
| Usage | TRANSDERMAL |
| Start Marketing Date | 20140416 |
| Marketing Category Name | ANDA |
| Application Number | ANDA200910 |
| Manufacturer | Mylan Pharmaceuticals Inc. |
| Substance Name | ETHINYL ESTRADIOL; NORELGESTROMIN |
| Strength | 35; 150 |
| Strength Unit | ug/d; ug/d |
| Pharmacy Classes | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |