aurovela 1/20

Generic: norethindrone acetate and ethinyl estradiol

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aurovela 1/20
Generic Name norethindrone acetate and ethinyl estradiol
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol 20 ug/1, norethindrone acetate 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-939
Product ID 65862-939_e42c0b14-e08a-4e77-8ead-8b44fb472f5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207506
Listing Expiration 2026-12-31
Marketing Start 2017-06-16

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 65862939
Hyphenated Format 65862-939

Supplemental Identifiers

RxCUI
1358762 1358776 1927366
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 aurovela 1/20 (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA207506 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/1
  • 1 mg/1
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
  • 3 POUCH in 1 CARTON (65862-939-88) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

65862-939-54 5 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK 65862-939-88 3 POUCH in 1 CARTON (65862-939-88) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (20 ug/1) norethindrone acetate (1 mg/1)

Linked Drug Pages (1)

Aurovela 1/20 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e42c0b14-e08a-4e77-8ead-8b44fb472f5f", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776", "1927366"], "spl_set_id": ["6765becf-7b51-4f33-ac13-70fcd01decf7"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (65862-939-54)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "65862-939-54", "marketing_start_date": "20170616"}, {"sample": false, "description": "3 POUCH in 1 CARTON (65862-939-88)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "65862-939-88", "marketing_start_date": "20170616"}], "brand_name": "Aurovela 1/20", "product_id": "65862-939_e42c0b14-e08a-4e77-8ead-8b44fb472f5f", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "65862-939", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aurovela 1/20", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "20 ug/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1 mg/1"}], "application_number": "ANDA207506", "marketing_category": "ANDA", "marketing_start_date": "20170616", "listing_expiration_date": "20261231"}