tri-vylibra

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
Generic Name norgestimate and ethinyl estradiol
Labeler afaxys pharma, llc
Dosage Form KIT
Manufacturer
Afaxys Pharma, LLC

Identifiers & Regulatory

Product NDC 50102-233
Product ID 50102-233_8f45527d-e6cf-4eda-ac01-29618a778122
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205441
Listing Expiration 2026-12-31
Marketing Start 2016-07-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50102233
Hyphenated Format 50102-233

Supplemental Identifiers

RxCUI
240128 406396 687424 748797 749784 1994764

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 (source: ndc)
Generic Name norgestimate and ethinyl estradiol (source: ndc)
Application Number ANDA205441 (source: ndc)

Resolved Composition

Strengths
  • 0.180 mg
  • 0.035 mg
  • 0.215 mg
  • 0.250 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (50102-233-11) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (50102-233-13) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

50102-233-11 1 BLISTER PACK in 1 CARTON (50102-233-11) / 1 KIT in 1 BLISTER PACK 50102-233-13 3 BLISTER PACK in 1 CARTON (50102-233-13) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Tri-VyLibra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "8f45527d-e6cf-4eda-ac01-29618a778122", "openfda": {"rxcui": ["240128", "406396", "687424", "748797", "749784", "1994764"], "spl_set_id": ["f59acc3e-21d9-4fa3-ad52-d77225739e1a"], "manufacturer_name": ["Afaxys Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50102-233-11)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50102-233-11", "marketing_start_date": "20160706"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50102-233-13)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50102-233-13", "marketing_start_date": "20160706"}], "brand_name": "Tri-VyLibra", "product_id": "50102-233_8f45527d-e6cf-4eda-ac01-29618a778122", "dosage_form": "KIT", "product_ndc": "50102-233", "generic_name": "Norgestimate and Ethinyl Estradiol", "labeler_name": "Afaxys Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tri-VyLibra", "application_number": "ANDA205441", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}