lutera

Generic: levonorgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name lutera
Generic Name levonorgestrel and ethinyl estradiol
Labeler mayne pharma inc.
Dosage Form KIT
Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-028
Product ID 51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076625
Listing Expiration 2026-12-31
Marketing Start 2016-08-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862028
Hyphenated Format 51862-028

Supplemental Identifiers

RxCUI
242297 748797 748868 751884

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 lutera (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA076625 (source: ndc)

Resolved Composition

Strengths
  • 0.1 mg
  • 0.02 mg
source: label
Packaging
  • 6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01)
source: ndc

Packages (1)

51862-028-06 6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Lutera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "bf6c876c-12de-48e8-a9f2-cf74ee3338f1", "openfda": {"rxcui": ["242297", "748797", "748868", "751884"], "spl_set_id": ["b91ad328-f2f4-4f7d-82d3-daaada95f509"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (51862-028-06)  / 1 KIT in 1 BLISTER PACK (51862-028-01)", "package_ndc": "51862-028-06", "marketing_end_date": "20260430", "marketing_start_date": "20160803"}], "brand_name": "Lutera", "product_id": "51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1", "dosage_form": "KIT", "product_ndc": "51862-028", "generic_name": "levonorgestrel and ethinyl estradiol", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lutera", "application_number": "ANDA076625", "marketing_category": "ANDA", "marketing_start_date": "20160803", "listing_expiration_date": "20261231"}