zumandimine

Generic: drospirenone and ethinyl estradiol

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zumandimine
Generic Name drospirenone and ethinyl estradiol
Labeler aurobindo pharma limited
Dosage Form KIT
Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-030
Product ID 59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209407
Listing Expiration 2026-12-31
Marketing Start 2018-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651030
Hyphenated Format 59651-030

Supplemental Identifiers

RxCUI
284207 748797 748800 2045196

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 zumandimine (source: ndc)
Generic Name drospirenone and ethinyl estradiol (source: ndc)
Application Number ANDA209407 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 0.03 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACK
  • 1 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • 3 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (4)

59651-030-28 1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK 59651-030-85 3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACK 59651-030-87 1 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 59651-030-88 3 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Zumandimine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "7cec3990-8d5f-4585-8bbc-fe2556cf69f5", "openfda": {"rxcui": ["284207", "748797", "748800", "2045196"], "spl_set_id": ["192ad3b0-9ef2-409d-a851-77712202c45a"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-030-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "59651-030-28", "marketing_start_date": "20180326"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59651-030-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "59651-030-85", "marketing_start_date": "20180326"}, {"sample": false, "description": "1 POUCH in 1 CARTON (59651-030-87)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "59651-030-87", "marketing_start_date": "20180326"}, {"sample": false, "description": "3 POUCH in 1 CARTON (59651-030-88)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "59651-030-88", "marketing_start_date": "20180326"}], "brand_name": "Zumandimine", "product_id": "59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5", "dosage_form": "KIT", "product_ndc": "59651-030", "generic_name": "Drospirenone and Ethinyl Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zumandimine", "application_number": "ANDA209407", "marketing_category": "ANDA", "marketing_start_date": "20180326", "listing_expiration_date": "20261231"}