norelgestromin and ethinyl estradiol

Generic: norelgestromin and ethinyl estradiol

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norelgestromin and ethinyl estradiol
Generic Name norelgestromin and ethinyl estradiol
Labeler zydus pharmaceuticals usa inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

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

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1190
Product ID 70710-1190_a84f4c06-76a6-4d38-b9d9-5a78bc2ad64f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214594
Listing Expiration 2026-12-31
Marketing Start 2023-11-21

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 707101190
Hyphenated Format 70710-1190

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 ethinyl estradiol (source: ndc)
Generic Name norelgestromin and ethinyl estradiol (source: ndc)
Application Number ANDA214594 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 35 ug/mg
  • 150 ug/mg
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCH
source: ndc

Packages (1)

70710-1190-3 3 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCH

Ingredients (2)

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

Linked Drug Pages (1)

norelgestromin and ethinyl estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "a84f4c06-76a6-4d38-b9d9-5a78bc2ad64f", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809"], "spl_set_id": ["10fa1458-c8ed-4197-922a-1ba7271d2b02"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70710-1190-3)  / 1 POUCH in 1 POUCH (70710-1190-1)  / 7 mg in 1 POUCH", "package_ndc": "70710-1190-3", "marketing_start_date": "20231121"}], "brand_name": "norelgestromin and ethinyl estradiol", "product_id": "70710-1190_a84f4c06-76a6-4d38-b9d9-5a78bc2ad64f", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70710-1190", "generic_name": "norelgestromin and ethinyl estradiol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "norelgestromin and ethinyl estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "35 ug/mg"}, {"name": "NORELGESTROMIN", "strength": "150 ug/mg"}], "application_number": "ANDA214594", "marketing_category": "ANDA", "marketing_start_date": "20231121", "listing_expiration_date": "20261231"}