drospirenone and ethinyl estradiol

Generic: drospirenone and ethinyl estradiol

Labeler: mylan 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 mylan pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7300
Product ID 0378-7300_29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202131
Listing Expiration 2026-12-31
Marketing Start 2015-08-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787300
Hyphenated Format 0378-7300

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 ANDA202131 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 0.03 mg
  • 3 mg/0.03 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (0378-7300-53) / 1 BLISTER PACK in 1 POUCH (0378-7300-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7300-53 3 POUCH in 1 CARTON (0378-7300-53) / 1 BLISTER PACK in 1 POUCH (0378-7300-85) / 1 KIT 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": "29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63f", "openfda": {"rxcui": ["284207", "748797", "748800"], "spl_set_id": ["25f9b952-cc1d-454e-a3ec-834ba1774b6b"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7300-53)  / 1 BLISTER PACK in 1 POUCH (0378-7300-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-7300-53", "marketing_start_date": "20150828"}], "brand_name": "DROSPIRENONE AND ETHINYL ESTRADIOL", "product_id": "0378-7300_29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63f", "dosage_form": "KIT", "product_ndc": "0378-7300", "generic_name": "drospirenone and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROSPIRENONE AND ETHINYL ESTRADIOL", "application_number": "ANDA202131", "marketing_category": "ANDA", "marketing_start_date": "20150828", "listing_expiration_date": "20261231"}