tri-vylibra lo

Generic: norgestimate and ethinyl estradiol

Labeler: afaxys pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tri-vylibra lo
Generic Name norgestimate and ethinyl estradiol
Labeler afaxys pharma, llc
Dosage Form KIT
Manufacturer
Afaxys Pharma, LLC

Identifiers & Regulatory

Product NDC 50102-231
Product ID 50102-231_bb0e872b-05ee-4e30-bc1f-808f2c533e5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205762
Listing Expiration 2026-12-31
Marketing Start 2016-11-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50102231
Hyphenated Format 50102-231

Supplemental Identifiers

RxCUI
578732 748797 749155 749156 749157 2104192

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 tri-vylibra lo (source: ndc)
Generic Name norgestimate and ethinyl estradiol (source: ndc)
Application Number ANDA205762 (source: ndc)

Resolved Composition

Strengths
  • 0.180 mg
  • 0.025 mg
  • 0.215 mg
  • 0.250 mg
source: label
Packaging
  • 3 PACKAGE in 1 CARTON (50102-231-13) / 1 BLISTER PACK in 1 PACKAGE (50102-231-11) / 1 KIT in 1 BLISTER PACK (50102-231-01)
source: ndc

Packages (1)

50102-231-13 3 PACKAGE in 1 CARTON (50102-231-13) / 1 BLISTER PACK in 1 PACKAGE (50102-231-11) / 1 KIT in 1 BLISTER PACK (50102-231-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Tri-VyLibra Lo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "bb0e872b-05ee-4e30-bc1f-808f2c533e5d", "openfda": {"rxcui": ["578732", "748797", "749155", "749156", "749157", "2104192"], "spl_set_id": ["bd51a08e-cd45-4315-9bca-41794450ef16"], "manufacturer_name": ["Afaxys Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 PACKAGE in 1 CARTON (50102-231-13)  / 1 BLISTER PACK in 1 PACKAGE (50102-231-11)  / 1 KIT in 1 BLISTER PACK (50102-231-01)", "package_ndc": "50102-231-13", "marketing_start_date": "20161104"}], "brand_name": "Tri-VyLibra Lo", "product_id": "50102-231_bb0e872b-05ee-4e30-bc1f-808f2c533e5d", "dosage_form": "KIT", "product_ndc": "50102-231", "generic_name": "Norgestimate and Ethinyl Estradiol", "labeler_name": "Afaxys Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tri-VyLibra Lo", "application_number": "ANDA205762", "marketing_category": "ANDA", "marketing_start_date": "20161104", "listing_expiration_date": "20261231"}