azurette

Generic: desogestrel/ethinyl estradiol and ethinyl estradiol

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azurette
Generic Name desogestrel/ethinyl estradiol and ethinyl estradiol
Labeler mayne pharma inc.
Dosage Form KIT
Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-890
Product ID 51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091247
Listing Expiration 2026-12-31
Marketing Start 2020-10-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862890
Hyphenated Format 51862-890

Supplemental Identifiers

RxCUI
248310 249357 748797 759743 831872

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 azurette (source: ndc)
Generic Name desogestrel/ethinyl estradiol and ethinyl estradiol (source: ndc)
Application Number ANDA091247 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.02 mg
  • 0.01 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (3)

51862-890-01 1 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACK 51862-890-02 1 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACK 51862-890-03 3 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Azurette ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "0f94b0b9-a7da-4030-9acf-542d6607d7fb", "openfda": {"rxcui": ["248310", "249357", "748797", "759743", "831872"], "spl_set_id": ["bff09a7b-aea6-460b-a263-44576e00f510"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (51862-890-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "51862-890-01", "marketing_start_date": "20201003"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51862-890-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "51862-890-02", "marketing_start_date": "20201003"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51862-890-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "51862-890-03", "marketing_start_date": "20201003"}], "brand_name": "Azurette", "product_id": "51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fb", "dosage_form": "KIT", "product_ndc": "51862-890", "generic_name": "desogestrel/ethinyl estradiol and ethinyl estradiol", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azurette", "application_number": "ANDA091247", "marketing_category": "ANDA", "marketing_start_date": "20201003", "listing_expiration_date": "20261231"}