estradiol and norethindrone acetate

Generic: estradiol and norethindrone acetate

Labeler: naari pte. limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol and norethindrone acetate
Generic Name estradiol and norethindrone acetate
Labeler naari pte. limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol 1 mg/1, norethindrone acetate .5 mg/1

Manufacturer
Naari Pte. Limited

Identifiers & Regulatory

Product NDC 79929-012
Product ID 79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210233
Listing Expiration 2026-12-31
Marketing Start 2024-06-11

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 79929012
Hyphenated Format 79929-012

Supplemental Identifiers

RxCUI
1359126 1359127
UPC
0379929012075
UNII
4TI98Z838E 9S44LIC7OJ
NUI
M0447348 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 estradiol and norethindrone acetate (source: ndc)
Generic Name estradiol and norethindrone acetate (source: ndc)
Application Number ANDA210233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 84 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

79929-012-07 84 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACK

Ingredients (2)

estradiol (1 mg/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

ESTRADIOL AND NORETHINDRONE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a990fcf-1731-8ca1-e063-6294a90ac9c8", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0379929012075"], "unii": ["4TI98Z838E", "9S44LIC7OJ"], "rxcui": ["1359126", "1359127"], "spl_set_id": ["f70185fe-9fcf-655f-e053-6394a90a20dc"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Naari Pte. Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "84 BLISTER PACK in 1 POUCH (79929-012-07)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "79929-012-07", "marketing_start_date": "20240611"}], "brand_name": "ESTRADIOL AND NORETHINDRONE ACETATE", "product_id": "79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "79929-012", "generic_name": "estradiol and norethindrone acetate", "labeler_name": "Naari Pte. Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRADIOL AND NORETHINDRONE ACETATE", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA210233", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20261231"}