norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol
Generic Name norethindrone acetate and ethinyl estradiol
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol .02 mg/1, norethindrone acetate 1 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6782
Product ID 50090-6782_0c0d4259-230e-46dd-b857-928cfc6808fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206969
Listing Expiration 2026-12-31
Marketing Start 2016-01-20

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 500906782
Hyphenated Format 50090-6782

Supplemental Identifiers

RxCUI
1358762 1358776
UNII
423D2T571U 9S44LIC7OJ
NUI
N0000175825 N0000000100

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 ANDA206969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .02 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50090-6782-0) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

50090-6782-0 1 BLISTER PACK in 1 CARTON (50090-6782-0) / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (.02 mg/1) norethindrone acetate (1 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": "0c0d4259-230e-46dd-b857-928cfc6808fd", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776"], "spl_set_id": ["38924c83-53aa-4279-8f0e-1a5d8f5fd8ad"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-6782-0)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "50090-6782-0", "marketing_start_date": "20231030"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol", "product_id": "50090-6782_0c0d4259-230e-46dd-b857-928cfc6808fd", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50090-6782", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".02 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1 mg/1"}], "application_number": "ANDA206969", "marketing_category": "ANDA", "marketing_start_date": "20160120", "listing_expiration_date": "20261231"}