vylibra

Generic: norgestimate and ethinyl estradiol

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 50102-235
Product ID 50102-235_3fdecb52-8f86-4699-b7e9-6fff08a4267e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205449
Listing Expiration 2026-12-31
Marketing Start 2016-07-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50102235
Hyphenated Format 50102-235

Supplemental Identifiers

RxCUI
240128 748797 749860 1994758

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 vylibra (source: ndc)
Generic Name norgestimate and ethinyl estradiol (source: ndc)
Application Number ANDA205449 (source: ndc)

Resolved Composition

Strengths
  • 0.250 mg
  • 0.035 mg
  • 0.250 mg/0.035 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (50102-235-11) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (50102-235-13) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

50102-235-11 1 BLISTER PACK in 1 CARTON (50102-235-11) / 1 KIT in 1 BLISTER PACK 50102-235-13 3 BLISTER PACK in 1 CARTON (50102-235-13) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VyLibra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "3fdecb52-8f86-4699-b7e9-6fff08a4267e", "openfda": {"rxcui": ["240128", "748797", "749860", "1994758"], "spl_set_id": ["13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3"], "manufacturer_name": ["Afaxys Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50102-235-11)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50102-235-11", "marketing_start_date": "20160707"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50102-235-13)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50102-235-13", "marketing_start_date": "20160707"}], "brand_name": "VyLibra", "product_id": "50102-235_3fdecb52-8f86-4699-b7e9-6fff08a4267e", "dosage_form": "KIT", "product_ndc": "50102-235", "generic_name": "norgestimate and ethinyl estradiol", "labeler_name": "Afaxys Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VyLibra", "application_number": "ANDA205449", "marketing_category": "ANDA", "marketing_start_date": "20160707", "listing_expiration_date": "20261231"}