simpesse

Generic: levonorgestrel and ethinyl estradiol and ethinyl estradiol

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 65862-864
Product ID 65862-864_bd9d6e25-de56-422b-9155-89378c5b943f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206851
Listing Expiration 2026-12-31
Marketing Start 2017-04-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862864
Hyphenated Format 65862-864

Supplemental Identifiers

RxCUI
238019 248310 749761 1918056

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 simpesse (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol and ethinyl estradiol (source: ndc)
Application Number ANDA206851 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.03 mg
  • 0.01 mg
  • 0.15 mg/0.03 mg
source: label
Packaging
  • 2 POUCH in 1 CARTON (65862-864-95) / 1 BLISTER PACK in 1 POUCH (65862-864-94) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

65862-864-95 2 POUCH in 1 CARTON (65862-864-95) / 1 BLISTER PACK in 1 POUCH (65862-864-94) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Simpesse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "bd9d6e25-de56-422b-9155-89378c5b943f", "openfda": {"rxcui": ["238019", "248310", "749761", "1918056"], "spl_set_id": ["abea62b3-6a55-40a4-9e68-1ee9801e0f2c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 CARTON (65862-864-95)  / 1 BLISTER PACK in 1 POUCH (65862-864-94)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-864-95", "marketing_start_date": "20170407"}], "brand_name": "Simpesse", "product_id": "65862-864_bd9d6e25-de56-422b-9155-89378c5b943f", "dosage_form": "KIT", "product_ndc": "65862-864", "generic_name": "Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simpesse", "application_number": "ANDA206851", "marketing_category": "ANDA", "marketing_start_date": "20170407", "listing_expiration_date": "20261231"}