zafemy

Generic: norelgestromin and ethinyl estradiol

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafemy
Generic Name norelgestromin and ethinyl estradiol
Labeler amneal pharmaceuticals llc
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

ethinyl estradiol 35 ug/d, norelgestromin 150 ug/d

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-358
Product ID 65162-358_4370e72b-f961-453e-ab06-5d933a6f5b50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213950
Listing Expiration 2026-12-31
Marketing Start 2020-06-28

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162358
Hyphenated Format 65162-358

Supplemental Identifiers

RxCUI
1534809 2531285
UNII
423D2T571U R0TAY3X631
NUI
N0000175825 N0000000100 M0447349 N0000175602

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zafemy (source: ndc)
Generic Name norelgestromin and ethinyl estradiol (source: ndc)
Application Number ANDA213950 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 35 ug/d
  • 150 ug/d
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH
source: ndc

Packages (1)

65162-358-03 3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH

Ingredients (2)

ethinyl estradiol (35 ug/d) norelgestromin (150 ug/d)

Linked Drug Pages (1)

ZAFEMY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "4370e72b-f961-453e-ab06-5d933a6f5b50", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809", "2531285"], "spl_set_id": ["5ee34c07-65af-42b8-a98f-e299ff90a8a1"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (65162-358-03)  / 1 PATCH in 1 POUCH (65162-358-01)  / 7 d in 1 PATCH", "package_ndc": "65162-358-03", "marketing_start_date": "20200630"}], "brand_name": "ZAFEMY", "product_id": "65162-358_4370e72b-f961-453e-ab06-5d933a6f5b50", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "65162-358", "generic_name": "Norelgestromin and Ethinyl Estradiol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZAFEMY", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "35 ug/d"}, {"name": "NORELGESTROMIN", "strength": "150 ug/d"}], "application_number": "ANDA213950", "marketing_category": "ANDA", "marketing_start_date": "20200628", "listing_expiration_date": "20261231"}