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NDC 65162-0358-03 ZAFEMY 35; 150 ug/d; ug/d Details
ZAFEMY 35; 150 ug/d; ug/d
ZAFEMY is a TRANSDERMAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ETHINYL ESTRADIOL; NORELGESTROMIN.
MedlinePlus Drug Summary
Estrogen and progestin transdermal (patch) contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (levonorgestrel or norelgestromin) are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries) and by changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of human immunodeficiency virus (HIV; the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 65162-0358-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Estrogen and Progestin (Transdermal Patch Contraceptives)
Product Information
| NDC | 65162-0358 |
|---|---|
| Product ID | 65162-358_ef9569cc-946a-467d-835c-3a7602d6eabc |
| Associated GPIs | 25960002508820 |
| GCN Sequence Number | 049828 |
| GCN Sequence Number Description | norelgestromin/ethin.estradiol PATCH TDWK 150-35/24H TRANSDERM |
| HIC3 | G8F |
| HIC3 Description | CONTRACEPTIVES,TRANSDERMAL |
| GCN | 15524 |
| HICL Sequence Number | 023235 |
| HICL Sequence Number Description | NORELGESTROMIN/ETHINYL ESTRADIOL |
| Brand/Generic | Generic |
| Proprietary Name | ZAFEMY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Norelgestromin and Ethinyl Estradiol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PATCH |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 35; 150 |
| Active Ingredient Units | ug/d; ug/d |
| Substance Name | ETHINYL ESTRADIOL; NORELGESTROMIN |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213950 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0358-03 (65162035803)
| NDC Package Code | 65162-358-03 |
|---|---|
| Billing NDC | 65162035803 |
| Package | 3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH |
| Marketing Start Date | 2020-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 34.5269 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ZAFEMY 150-35 MCG/DAY PATCH |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |