drospirenone and ethinyl estradiol

Generic: drospirenone and ethinyl estradiol

Labeler: lupin pharmaceuticals, inc.
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 lupin pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-868
Product ID 68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201663
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180868
Hyphenated Format 68180-868

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 ANDA201663 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 0.03 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (68180-868-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (68180-913-74) * 21 TABLET in 1 BLISTER PACK (68180-912-74)
source: ndc

Packages (1)

68180-868-73 3 POUCH in 1 CARTON (68180-868-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (68180-913-74) * 21 TABLET in 1 BLISTER PACK (68180-912-74)

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": "3c3a2ddd-8711-416c-813e-63c64f579ac2", "openfda": {"rxcui": ["284207", "748797", "748800"], "spl_set_id": ["a8955f3b-afc9-4ef0-8946-9c97ab5b2e05"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (68180-868-73)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK *  7 TABLET in 1 BLISTER PACK (68180-913-74)  *  21 TABLET in 1 BLISTER PACK (68180-912-74)", "package_ndc": "68180-868-73", "marketing_start_date": "20220415"}], "brand_name": "DROSPIRENONE AND ETHINYL ESTRADIOL", "product_id": "68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2", "dosage_form": "KIT", "product_ndc": "68180-868", "generic_name": "DROSPIRENONE AND ETHINYL ESTRADIOL", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROSPIRENONE AND ETHINYL ESTRADIOL", "application_number": "ANDA201663", "marketing_category": "ANDA", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}