econtra one-step

Generic: levonorgestrel

Labeler: afaxys pharma, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name econtra one-step
Generic Name levonorgestrel
Labeler afaxys pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Afaxys Pharma, LLC

Identifiers & Regulatory

Product NDC 50102-211
Product ID 50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206867
Listing Expiration 2026-12-31
Marketing Start 2018-02-08

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 50102211
Hyphenated Format 50102-211

Supplemental Identifiers

RxCUI
483325 1600602
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 econtra one-step (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA206867 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 3 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01)
source: ndc

Packages (1)

50102-211-13 3 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01)

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

EContra One-Step ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d56023fd-6224-4727-bf3e-e5827dfe5f0a", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "1600602"], "spl_set_id": ["94b23c49-dfba-4a70-ada5-e5c212e703c5"], "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": ["Afaxys Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 PACKAGE (50102-211-13)  / 1 BLISTER PACK in 1 CARTON (50102-211-11)  / 1 TABLET in 1 BLISTER PACK (50102-211-01)", "package_ndc": "50102-211-13", "marketing_start_date": "20201027"}], "brand_name": "EContra One-Step", "product_id": "50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0a", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "50102-211", "generic_name": "Levonorgestrel", "labeler_name": "Afaxys Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "EContra One-Step", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA206867", "marketing_category": "ANDA", "marketing_start_date": "20180208", "listing_expiration_date": "20261231"}