safyral

Generic: drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name safyral
Generic Name drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-403
Product ID 50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022574
Listing Expiration 2027-12-31
Marketing Start 2012-02-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419403
Hyphenated Format 50419-403

Supplemental Identifiers

RxCUI
1013628 1050492 1050493 1050494

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 safyral (source: ndc)
Generic Name drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium (source: ndc)
Application Number NDA022574 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 0.03 mg
  • 0.451 mg
source: label
Packaging
  • 90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 PACKAGE (50419-403-03) / 1 KIT in 1 BLISTER PACK (50419-403-01)
  • 90 BLISTER PACK in 1 PACKAGE (50419-403-70) / 1 KIT in 1 BLISTER PACK
  • 12 PACKAGE in 1 CARTON (50419-403-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)
source: ndc

Packages (4)

50419-403-00 90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK 50419-403-03 3 BLISTER PACK in 1 PACKAGE (50419-403-03) / 1 KIT in 1 BLISTER PACK (50419-403-01) 50419-403-70 90 BLISTER PACK in 1 PACKAGE (50419-403-70) / 1 KIT in 1 BLISTER PACK 50419-403-75 12 PACKAGE in 1 CARTON (50419-403-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Safyral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e2c77609-66d5-4e76-8f2b-060c9e30b5e9", "openfda": {"rxcui": ["1013628", "1050492", "1050493", "1050494"], "spl_set_id": ["97563516-306a-4e17-9690-edbda49ecd83"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 BLISTER PACK in 1 PACKAGE (50419-403-00)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50419-403-00", "marketing_start_date": "20120213"}, {"sample": false, "description": "3 BLISTER PACK in 1 PACKAGE (50419-403-03)  / 1 KIT in 1 BLISTER PACK (50419-403-01)", "package_ndc": "50419-403-03", "marketing_start_date": "20120213"}, {"sample": false, "description": "90 BLISTER PACK in 1 PACKAGE (50419-403-70)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "50419-403-70", "marketing_start_date": "20120213"}, {"sample": false, "description": "12 PACKAGE in 1 CARTON (50419-403-75)  / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)", "package_ndc": "50419-403-75", "marketing_start_date": "20120213"}], "brand_name": "Safyral", "product_id": "50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9", "dosage_form": "KIT", "product_ndc": "50419-403", "generic_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Safyral", "application_number": "NDA022574", "marketing_category": "NDA", "marketing_start_date": "20120213", "listing_expiration_date": "20271231"}