levonorgestrel and ethinyl estradiol

Generic: levonorgestrel and ethinyl estradiol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levonorgestrel and ethinyl estradiol
Generic Name levonorgestrel and ethinyl estradiol
Labeler mylan pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6550
Product ID 0378-6550_feeae783-e2d6-4d6f-9815-627228a6b23b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091663
Marketing Start 2013-08-16
Marketing End 2026-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786550
Hyphenated Format 0378-6550

Supplemental Identifiers

RxCUI
238019 748797 748878

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 levonorgestrel and ethinyl estradiol (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA091663 (source: ndc)

Resolved Composition

Packaging
  • 3 POUCH in 1 CARTON (0378-6550-53) / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-6550-53 3 POUCH in 1 CARTON (0378-6550-53) / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LEVONORGESTREL AND ETHINYL ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "feeae783-e2d6-4d6f-9815-627228a6b23b", "openfda": {"rxcui": ["238019", "748797", "748878"], "spl_set_id": ["27178b07-42bd-496d-aebb-d9428664ee72"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-6550-53)  / 1 BLISTER PACK in 1 POUCH (0378-6550-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-6550-53", "marketing_end_date": "20260630", "marketing_start_date": "20130816"}], "brand_name": "LEVONORGESTREL AND ETHINYL ESTRADIOL", "product_id": "0378-6550_feeae783-e2d6-4d6f-9815-627228a6b23b", "dosage_form": "KIT", "product_ndc": "0378-6550", "generic_name": "levonorgestrel and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVONORGESTREL AND ETHINYL ESTRADIOL", "application_number": "ANDA091663", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20130816"}