drospirenone and ethinyl estradiol

Generic: drospirenone and ethinyl estradiol

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name drospirenone and ethinyl estradiol
Generic Name drospirenone and ethinyl estradiol
Labeler apotex corp.
Dosage Form KIT
Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4897
Product ID 60505-4897_494e21bb-c954-9295-e063-6294a90ab80a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207245
Listing Expiration 2027-12-31
Marketing Start 2026-01-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054897
Hyphenated Format 60505-4897

Supplemental Identifiers

RxCUI
284207 748797 748800

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 and ethinyl estradiol (source: ndc)
Generic Name drospirenone and ethinyl estradiol (source: ndc)
Application Number ANDA207245 (source: ndc)

Resolved Composition

Strengths
  • 3 mg/0.03 mg
  • 3 mg
  • 0.03 mg
source: label
Packaging
  • 3 BLISTER PACK in 1 POUCH (60505-4897-8) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

60505-4897-8 3 BLISTER PACK in 1 POUCH (60505-4897-8) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

DROSPIRENONE AND ETHINYL ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "494e21bb-c954-9295-e063-6294a90ab80a", "openfda": {"rxcui": ["284207", "748797", "748800"], "spl_set_id": ["9187a357-e95d-4733-9627-f19522b86373"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 POUCH (60505-4897-8)  / 1 KIT in 1 BLISTER PACK *  7 TABLET in 1 BLISTER PACK *  21 TABLET in 1 BLISTER PACK", "package_ndc": "60505-4897-8", "marketing_start_date": "20260126"}], "brand_name": "DROSPIRENONE AND ETHINYL ESTRADIOL", "product_id": "60505-4897_494e21bb-c954-9295-e063-6294a90ab80a", "dosage_form": "KIT", "product_ndc": "60505-4897", "generic_name": "DROSPIRENONE AND ETHINYL ESTRADIOL", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROSPIRENONE AND ETHINYL ESTRADIOL", "application_number": "ANDA207245", "marketing_category": "ANDA", "marketing_start_date": "20260126", "listing_expiration_date": "20271231"}