low-ogestrel

Generic: norgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name low-ogestrel
Generic Name norgestrel and ethinyl estradiol
Labeler mayne pharma inc.
Dosage Form KIT
Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-564
Product ID 51862-564_051f62cc-9a4a-40bc-9a9b-e7942354c0dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075288
Marketing Start 2016-08-03
Marketing End 2027-01-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862564
Hyphenated Format 51862-564

Supplemental Identifiers

RxCUI
311359 748797 749786 750244

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 low-ogestrel (source: ndc)
Generic Name norgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA075288 (source: ndc)

Resolved Composition

Strengths
  • 0.3 mg
  • 0.03 mg
source: label
Packaging
  • 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)
source: ndc

Packages (1)

51862-564-06 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Low-Ogestrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "051f62cc-9a4a-40bc-9a9b-e7942354c0dc", "openfda": {"rxcui": ["311359", "748797", "749786", "750244"], "spl_set_id": ["8755b020-d439-4ba2-a60b-6c57a15ece55"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (51862-564-06)  / 1 KIT in 1 BLISTER PACK (51862-564-01)", "package_ndc": "51862-564-06", "marketing_end_date": "20270131", "marketing_start_date": "20160803"}], "brand_name": "Low-Ogestrel", "product_id": "51862-564_051f62cc-9a4a-40bc-9a9b-e7942354c0dc", "dosage_form": "KIT", "product_ndc": "51862-564", "generic_name": "Norgestrel and Ethinyl Estradiol", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Low-Ogestrel", "application_number": "ANDA075288", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20160803"}