amethia

Generic: ethinyl estradiol and levonorgestrel

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 51862-047
Product ID 51862-047_129c30f2-85d6-59ee-e063-6294a90aef97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078834
Listing Expiration 2026-12-31
Marketing Start 2016-10-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862047
Hyphenated Format 51862-047

Supplemental Identifiers

RxCUI
238019 248310 749761 1112687

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 amethia (source: ndc)
Generic Name ethinyl estradiol and levonorgestrel (source: ndc)
Application Number ANDA078834 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.03 mg
  • 0.01 mg
  • 0.15 mg/0.03 mg
source: label
Packaging
  • 16. HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied AMETHIA tablets, 0.15mg/0.03 mg and 0.01 mg are available in Extended-Cycle Tablet Dispensers (NDC 51862-047-01), each containing a 13-week supply of tablets: 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light blue tablets each containing 0.01 mg of ethinyl estradiol. The white tablets are round, flat face beveled edge, unscored tablets with WATSON on one side and 268 on the other side. The light blue tablets are round, flat face beveled edge, unscored tablets with WATSON on one side and 270 on the other side. Box of 2 Extended-Cycle Tablet Dispensers NDC 51862-047-91 16.2 Storage Conditions Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - Kit Carton NDC 51862-047-91 Amethia™ (Levonorgestrel/Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets, 0.15 mg/0.03 mg and 0.01 mg) Contains 2 Extended-Cycle Tablet Dispensers, each containing 91 tablets: 84 white tablets, each containing 0.15 mg levonorgestrel with 0.03 mg ethinyl estradiol, and 7 light blue tablets, each containing 0.01 mg ethinyl estradiol. Rx only 2 Extended-Cycle Tablet Dispensers, 91 Tablets Each maynepharma PRINCIPAL DISPLAY PANEL - Kit Carton
source: label

Packages (0)

No package records.

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Amethia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "129c30f2-85d6-59ee-e063-6294a90aef97", "openfda": {"rxcui": ["238019", "248310", "749761", "1112687"], "spl_set_id": ["d6a33ea7-ecd1-4f81-a984-f210a3989618"], "manufacturer_name": ["Mayne Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Amethia", "product_id": "51862-047_129c30f2-85d6-59ee-e063-6294a90aef97", "dosage_form": "KIT", "product_ndc": "51862-047", "generic_name": "ETHINYL ESTRADIOL and LEVONORGESTREL", "labeler_name": "Mayne Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amethia", "application_number": "ANDA078834", "marketing_category": "ANDA", "marketing_start_date": "20161012", "listing_expiration_date": "20261231"}