norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol

Labeler: glenmark pharmaceuticals inc., usa
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 glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-132
Product ID 68462-132_0f4e690d-1b9a-4c51-ac0a-8aa783056a00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206969
Listing Expiration 2027-12-31
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 68462132
Hyphenated Format 68462-132

Supplemental Identifiers

RxCUI
1358762 1358776
UPC
0368462132814 0368462132791
UNII
423D2T571U 9S44LIC7OJ
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 ANDA206969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .02 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (68462-132-81) / 1 BLISTER PACK in 1 POUCH (68462-132-79) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

68462-132-81 3 POUCH in 1 CARTON (68462-132-81) / 1 BLISTER PACK in 1 POUCH (68462-132-79) / 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": "0f4e690d-1b9a-4c51-ac0a-8aa783056a00", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0368462132814", "0368462132791"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776"], "spl_set_id": ["5a44f7a2-45f1-4d28-b9fb-61d9f2456422"], "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 (68462-132-81)  / 1 BLISTER PACK in 1 POUCH (68462-132-79)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "68462-132-81", "marketing_start_date": "20160120"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol", "product_id": "68462-132_0f4e690d-1b9a-4c51-ac0a-8aa783056a00", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-132", "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": ".02 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1 mg/1"}], "application_number": "ANDA206969", "marketing_category": "ANDA", "marketing_start_date": "20160120", "listing_expiration_date": "20271231"}