levora

Generic: levonorgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name levora
Generic Name levonorgestrel and ethinyl estradiol
Labeler mayne pharma inc.
Dosage Form KIT
Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-097
Product ID 51862-097_3aadc382-e2a4-019e-e063-6394a90a45c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073594
Listing Expiration 2026-12-31
Marketing Start 2016-08-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862097
Hyphenated Format 51862-097

Supplemental Identifiers

RxCUI
238019 748797 748878 748879

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 levora (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA073594 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg/0.03 mg
source: label
Packaging
  • HOW SUPPLIED/STORAGE AND HANDLING LEVORA ® 0.15/30-28 tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/0.03 mg) are available in packages of 6 compact dispensers, each containing 28 tablets: 21 Active Tablets: White, round, unscored, debossed with 15/30 on one side and WATSON on the other side. 7 Inert Tablets: Peach, round, unscored, debossed with WATSON on one side and P1 on the other side. NDC 51862-097-01 Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - Kit Carton NDC 51862-097-06 Levora ® 0.15/30-28 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg 28-DAY REGIMEN Each white tablet (21) contains levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg; each peach tablet (7) contains inert ingredients. Rx Only 6 Blister Cards, 28 Tablets Each mayne pharma PRINCIPAL DISPLAY PANEL - Kit Carton
source: label

Packages (0)

No package records.

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Levora ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "3aadc382-e2a4-019e-e063-6394a90a45c3", "openfda": {"rxcui": ["238019", "748797", "748878", "748879"], "spl_set_id": ["31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Levora", "product_id": "51862-097_3aadc382-e2a4-019e-e063-6394a90a45c3", "dosage_form": "KIT", "product_ndc": "51862-097", "generic_name": "levonorgestrel and ethinyl estradiol", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levora", "application_number": "ANDA073594", "marketing_category": "ANDA", "marketing_start_date": "20160803", "listing_expiration_date": "20261231"}