drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium

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

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Generic Name drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Labeler sandoz inc
Dosage Form KIT
Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-4103
Product ID 0781-4103_6471e7a9-16b1-4b84-a113-fe6ac0ca5640
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022574
Listing Expiration 2027-12-31
Marketing Start 2015-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07814103
Hyphenated Format 0781-4103

Supplemental Identifiers

RxCUI
1013628 1050492 1050493

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 drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium (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
  • 3 BLISTER PACK in 1 PACKAGE (0781-4103-15) / 1 KIT in 1 BLISTER PACK (0781-4103-52)
source: ndc

Packages (1)

0781-4103-15 3 BLISTER PACK in 1 PACKAGE (0781-4103-15) / 1 KIT in 1 BLISTER PACK (0781-4103-52)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "6471e7a9-16b1-4b84-a113-fe6ac0ca5640", "openfda": {"rxcui": ["1013628", "1050492", "1050493"], "spl_set_id": ["6928f186-190d-4c40-beab-81cf80cd45cb"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 PACKAGE (0781-4103-15)  / 1 KIT in 1 BLISTER PACK (0781-4103-52)", "package_ndc": "0781-4103-15", "marketing_start_date": "20150801"}], "brand_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium", "product_id": "0781-4103_6471e7a9-16b1-4b84-a113-fe6ac0ca5640", "dosage_form": "KIT", "product_ndc": "0781-4103", "generic_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium", "application_number": "NDA022574", "marketing_category": "NDA", "marketing_start_date": "20150801", "listing_expiration_date": "20271231"}