norethindrone acetate and ethinyl estradiol (68462-656)

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol

Generic Name norethindrone acetate and ethinyl estradiol

Labeler glenmark pharmaceuticals inc., usa

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ethinyl estradiol 2.5 ug/1, norethindrone acetate .5 mg/1

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-656

Product ID 68462-656_bc4774d0-9902-4678-af65-69d6a70d9983

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203038

Listing Expiration 2027-12-31

Marketing Start 2015-04-02

Pharmacologic Class

Established (EPC)

estrogen [epc]

Mechanism of Action

estrogen receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462656

Hyphenated Format 68462-656

Supplemental Identifiers

RxCUI

1090992 1251323 1251334 1251336

UPC

0368462657294 0368462656297

UNII

9S44LIC7OJ 423D2T571U

NUI

N0000175825 N0000000100

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 norethindrone acetate and ethinyl estradiol (source: ndc)

Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)

Application Number ANDA203038 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 ug/1
.5 mg/1

source: ndc

Packaging

3 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
90 TABLET in 1 BOTTLE (68462-656-90)

source: ndc

Packages (2)

68462-656-29 3 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK 68462-656-90 90 TABLET in 1 BOTTLE (68462-656-90)

Ingredients (2)

ethinyl estradiol (2.5 ug/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

Norethindrone Acetate and Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "bc4774d0-9902-4678-af65-69d6a70d9983", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0368462657294", "0368462656297"], "unii": ["9S44LIC7OJ", "423D2T571U"], "rxcui": ["1090992", "1251323", "1251334", "1251336"], "spl_set_id": ["cf549b5a-2707-4020-9f94-dab1260e1664"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (68462-656-29)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK", "package_ndc": "68462-656-29", "marketing_start_date": "20150402"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-656-90)", "package_ndc": "68462-656-90", "marketing_start_date": "20150402"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol", "product_id": "68462-656_bc4774d0-9902-4678-af65-69d6a70d9983", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-656", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "2.5 ug/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA203038", "marketing_category": "ANDA", "marketing_start_date": "20150402", "listing_expiration_date": "20271231"}