ithappenz morning after (58602-892)

Drug Facts

Product Profile

Brand Name ithappenz morning after

Generic Name levonorgestrel

Labeler aurohealth llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-892

Product ID 58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA206867

Listing Expiration 2026-12-31

Marketing Start 2022-11-14

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 58602892

Hyphenated Format 58602-892

Supplemental Identifiers

RxCUI

483325 2632742

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 ithappenz morning after (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

1 BLISTER PACK in 1 CARTON (58602-892-57) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

58602-892-57 1 BLISTER PACK in 1 CARTON (58602-892-57) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

ITHAPPENZ MORNING AFTER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "6c3a0c42-b783-4b9f-a801-7b128ae38ff4", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2632742"], "spl_set_id": ["5ee40793-0121-4b8f-b20d-3178bbe262e2"], "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": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-892-57)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "58602-892-57", "marketing_start_date": "20221114"}], "brand_name": "ITHAPPENZ MORNING AFTER", "product_id": "58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "58602-892", "generic_name": "Levonorgestrel", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ITHAPPENZ MORNING AFTER", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA206867", "marketing_category": "ANDA", "marketing_start_date": "20221114", "listing_expiration_date": "20261231"}