norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol

Labeler: mylan pharmaceuticals inc.
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 mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7280
Product ID 0378-7280_e450353d-021c-b48d-d1ea-0787a1561ae2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202771
Listing Expiration 2026-12-31
Marketing Start 2014-07-11

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 03787280
Hyphenated Format 0378-7280

Supplemental Identifiers

RxCUI
1358762 1358776
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 ANDA202771 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .02 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (0378-7280-53) / 1 BLISTER PACK in 1 POUCH (0378-7280-85) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7280-53 3 POUCH in 1 CARTON (0378-7280-53) / 1 BLISTER PACK in 1 POUCH (0378-7280-85) / 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": "e450353d-021c-b48d-d1ea-0787a1561ae2", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776"], "spl_set_id": ["89948751-bd6e-4e9c-b87c-8782706c1097"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7280-53)  / 1 BLISTER PACK in 1 POUCH (0378-7280-85)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "0378-7280-53", "marketing_start_date": "20141107"}], "brand_name": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL", "product_id": "0378-7280_e450353d-021c-b48d-d1ea-0787a1561ae2", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0378-7280", "generic_name": "norethindrone acetate and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "ANDA202771", "marketing_category": "ANDA", "marketing_start_date": "20140711", "listing_expiration_date": "20261231"}