nextstellis

Generic: drospirenone and estetrol

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nextstellis
Generic Name drospirenone and estetrol
Labeler mayne pharma
Dosage Form KIT
Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 51862-258
Product ID 51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214154
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862258
Hyphenated Format 51862-258

Supplemental Identifiers

RxCUI
748797 2539032 2539033 2539036

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 nextstellis (source: ndc)
Generic Name drospirenone and estetrol (source: ndc)
Application Number NDA214154 (source: ndc)

Resolved Composition

Strengths
  • 3 mg
  • 14.2 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)
  • 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)
source: ndc

Packages (2)

51862-258-00 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) 51862-258-01 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Nextstellis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "cb3d0738-1ec9-47a9-9167-8a4eb905ddab", "openfda": {"rxcui": ["748797", "2539032", "2539033", "2539036"], "spl_set_id": ["c5270073-d083-4109-ae4b-156986175e0a"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (51862-258-00)  / 1 KIT in 1 BLISTER PACK *  24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24)  *  4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)", "package_ndc": "51862-258-00", "marketing_start_date": "20210416"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51862-258-01)  / 1 KIT in 1 BLISTER PACK *  24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24)  *  4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)", "package_ndc": "51862-258-01", "marketing_start_date": "20210416"}], "brand_name": "Nextstellis", "product_id": "51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab", "dosage_form": "KIT", "product_ndc": "51862-258", "generic_name": "drospirenone and estetrol", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nextstellis", "application_number": "NDA214154", "marketing_category": "NDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}