leader emergency contraceptive levonorgestrel (70000-0600)

Drug Facts

Product Profile

Brand Name leader emergency contraceptive levonorgestrel

Generic Name levonorgestrel

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET

Routes

ORAL

Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer

Cardinal Health 110, LLC. DBA Leader

Identifiers & Regulatory

Product NDC 70000-0600

Product ID 70000-0600_22674ee5-1f31-4caa-aaed-96d3dd6d1b2f

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA202635

Listing Expiration 2026-12-31

Marketing Start 2022-03-22

Pharmacologic Class

Established (EPC)

progestin [epc] progestin-containing intrauterine system [epc]

Chemical Structure

progesterone congeners [cs]

Physiologic Effect

inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000600

Hyphenated Format 70000-0600

Supplemental Identifiers

RxCUI

483325

UPC

0096295141924

UNII

5W7SIA7YZW

NUI

N0000175830 M0447349 N0000175602 N0000175832

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 leader emergency contraceptive levonorgestrel (source: ndc)

Generic Name levonorgestrel (source: ndc)

Application Number ANDA202635 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1.5 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (70000-0600-1) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

70000-0600-1 1 BLISTER PACK in 1 CARTON (70000-0600-1) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

LEADER Emergency Contraceptive Levonorgestrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "22674ee5-1f31-4caa-aaed-96d3dd6d1b2f", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0096295141924"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["d1e33615-0a98-4223-833d-843c758d9db7"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "manufacturer_name": ["Cardinal Health 110, LLC. DBA Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70000-0600-1)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0600-1", "marketing_start_date": "20220322"}], "brand_name": "LEADER Emergency Contraceptive Levonorgestrel", "product_id": "70000-0600_22674ee5-1f31-4caa-aaed-96d3dd6d1b2f", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "70000-0600", "generic_name": "levonorgestrel", "labeler_name": "Cardinal Health 110, LLC. DBA Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LEADER Emergency Contraceptive Levonorgestrel", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202635", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20261231"}