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 AUTHORIZED GENERIC 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 0781-4075
Product ID 0781-4075_4f8e8c46-a43e-4b73-b4d2-63076f27113d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022532
Listing Expiration 2026-12-31
Marketing Start 2016-10-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07814075
Hyphenated Format 0781-4075

Supplemental Identifiers

RxCUI
1013626 1013628 1013629

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 NDA022532 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 0.02 mg
  • 0.451 mg
source: label
Packaging
  • 3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52)
source: ndc

Packages (1)

0781-4075-15 3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52)

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": "4f8e8c46-a43e-4b73-b4d2-63076f27113d", "openfda": {"rxcui": ["1013626", "1013628", "1013629"], "spl_set_id": ["58cd12d3-39b1-4375-b7e0-09ba2378a52b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0781-4075-15)  / 1 KIT in 1 BLISTER PACK (0781-4075-52)", "package_ndc": "0781-4075-15", "marketing_start_date": "20161012"}], "brand_name": "Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium", "product_id": "0781-4075_4f8e8c46-a43e-4b73-b4d2-63076f27113d", "dosage_form": "KIT", "product_ndc": "0781-4075", "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": "NDA022532", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20161012", "listing_expiration_date": "20261231"}