afirmelle

Generic: levonorgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 65862-849
Product ID 65862-849_47af327f-2969-4cbf-9aa8-39c8003df043
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206886
Listing Expiration 2026-12-31
Marketing Start 2016-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862849
Hyphenated Format 65862-849

Supplemental Identifiers

RxCUI
242297 748797 748868 1860414
UPC
0365862849281

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 afirmelle (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA206886 (source: ndc)

Resolved Composition

Strengths
  • 0.1 mg/0.02 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACK
  • 6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

65862-849-88 3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACK 65862-849-92 6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Afirmelle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "47af327f-2969-4cbf-9aa8-39c8003df043", "openfda": {"upc": ["0365862849281"], "rxcui": ["242297", "748797", "748868", "1860414"], "spl_set_id": ["dd6122cd-b7ba-4fe3-bde5-910882475b67"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (65862-849-88)  / 1 BLISTER PACK in 1 POUCH (65862-849-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-849-88", "marketing_start_date": "20161114"}, {"sample": false, "description": "6 POUCH in 1 CARTON (65862-849-92)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-849-92", "marketing_start_date": "20161114"}], "brand_name": "Afirmelle", "product_id": "65862-849_47af327f-2969-4cbf-9aa8-39c8003df043", "dosage_form": "KIT", "product_ndc": "65862-849", "generic_name": "Levonorgestrel and Ethinyl Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Afirmelle", "application_number": "ANDA206886", "marketing_category": "ANDA", "marketing_start_date": "20161114", "listing_expiration_date": "20261231"}