LEADER Emergency Contraceptive Levonorgestrel

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: LEADER Emergency Contraceptive Levonorgestrel
Generic name: LEVONORGESTREL
Manufacturer: Cardinal Health 110, LLC. DBA Leader
Product type: HUMAN OTC DRUG
SPL set ID: d1e33615-0a98-4223-833d-843c758d9db7
SPL ID: 51245457-71af-6325-e063-6394a90ade8b
Version: 5
Effective date: 2026-05-06
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:43

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	202635	derived:openfda.application_number
application number		ANDA202635	openfda.application_number
brand name		LEADER Emergency Contraceptive Levonorgestrel	openfda.brand_name
generic name		LEVONORGESTREL	openfda.generic_name
manufacturer name		Cardinal Health 110, LLC. DBA Leader	openfda.manufacturer_name
ndc	package	70000-0600-1	openfda.package_ndc
ndc	product	70000-0600	openfda.product_ndc
ndc11	package	70000060001	derived:openfda.package_ndc
rxcui		483325	openfda.rxcui
spl id		51245457-71af-6325-e063-6394a90ade8b	id
spl set id		d1e33615-0a98-4223-833d-843c758d9db7	set_id
unii		5W7SIA7YZW	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert This product does not protect against HIV/AIDS or other STDs. Do not use if you are already pregnant (because it will not work) for regular birth control Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel. When using this product you may have menstrual changes tiredness dizziness nausea headache breast pain lower stomach (abdominal) pain vomiting Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.