levonorgestrel and ethinyl estradiol and ethinyl estradiol

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

Identifiers & Regulatory

Product NDC 0378-7316
Product ID 0378-7316_ec0afe77-8394-9a0d-61c5-e2522c725ad9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206053
Listing Expiration 2026-12-31
Marketing Start 2017-10-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787316
Hyphenated Format 0378-7316

Supplemental Identifiers

RxCUI
238019 248310 1373501 1373502 1373503

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 and ethinyl estradiol (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol and ethinyl estradiol (source: ndc)
Application Number ANDA206053 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.02 mg
  • 0.025 mg
  • 0.03 mg
  • 0.01 mg
source: label
Packaging
  • 1 POUCH in 1 CARTON (0378-7316-85) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7316-85 1 POUCH in 1 CARTON (0378-7316-85) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ec0afe77-8394-9a0d-61c5-e2522c725ad9", "openfda": {"rxcui": ["238019", "248310", "1373501", "1373502", "1373503"], "spl_set_id": ["5c1d0a3a-1b24-44a0-9c53-224365b65945"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0378-7316-85)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-7316-85", "marketing_start_date": "20171002"}], "brand_name": "LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL", "product_id": "0378-7316_ec0afe77-8394-9a0d-61c5-e2522c725ad9", "dosage_form": "KIT", "product_ndc": "0378-7316", "generic_name": "levonorgestrel and ethinyl estradiol and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL", "application_number": "ANDA206053", "marketing_category": "ANDA", "marketing_start_date": "20171002", "listing_expiration_date": "20261231"}