norelgestromin and ethinly estradiol

Generic: norelgestromin and ethinly estradiol

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

Drug Facts

Product Profile

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

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

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1521
Product ID 69238-1521_0a63a330-c4d1-4fb0-8e11-10b2971f1a57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213950
Listing Expiration 2026-12-31
Marketing Start 2021-02-26

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 692381521
Hyphenated Format 69238-1521

Supplemental Identifiers

RxCUI
1534809
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 norelgestromin and ethinly estradiol (source: ndc)
Generic Name norelgestromin and ethinly 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 (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH
source: ndc

Packages (1)

69238-1521-3 3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH

Ingredients (2)

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

Linked Drug Pages (1)

Norelgestromin and Ethinly Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "0a63a330-c4d1-4fb0-8e11-10b2971f1a57", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809"], "spl_set_id": ["36445b6a-e0f2-42f7-a8f3-5b80c90b87dd"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (69238-1521-3)  / 1 PATCH in 1 POUCH (69238-1521-1)  / 7 d in 1 PATCH", "package_ndc": "69238-1521-3", "marketing_start_date": "20210226"}], "brand_name": "Norelgestromin and Ethinly Estradiol", "product_id": "69238-1521_0a63a330-c4d1-4fb0-8e11-10b2971f1a57", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "69238-1521", "generic_name": "Norelgestromin and Ethinly Estradiol", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norelgestromin and Ethinly Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "35 ug/d"}, {"name": "NORELGESTROMIN", "strength": "150 ug/d"}], "application_number": "ANDA213950", "marketing_category": "ANDA", "marketing_start_date": "20210226", "listing_expiration_date": "20261231"}