activella

Generic: estradiol/norethindrone acetate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name activella
Generic Name estradiol/norethindrone acetate
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 60846-231
Product ID 60846-231_ec312506-ea70-4aa1-8c07-0347fe956a57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020907
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 60846231
Hyphenated Format 60846-231

Supplemental Identifiers

RxCUI
1359123 1359124 1359125 1359126 1359127 1359128
UNII
9S44LIC7OJ 4TI98Z838E
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 activella (source: ndc)
Generic Name estradiol/norethindrone acetate (source: ndc)
Application Number NDA020907 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
  • .1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (60846-231-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

60846-231-01 1 BLISTER PACK in 1 CARTON (60846-231-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Activella ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ec312506-ea70-4aa1-8c07-0347fe956a57", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359125", "1359126", "1359127", "1359128"], "spl_set_id": ["d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (60846-231-01)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60846-231-01", "marketing_start_date": "20190501"}], "brand_name": "Activella", "product_id": "60846-231_ec312506-ea70-4aa1-8c07-0347fe956a57", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "60846-231", "generic_name": "Estradiol/norethindrone acetate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Activella", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".1 mg/1"}], "application_number": "NDA020907", "marketing_category": "NDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}