ITHAPPENZ MORNING AFTER

Product NDC
58602-892
11-digit product format
586020892
Labeler code
58602
Product ID
58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206867
Marketing category
ANDA
Marketing start
2022-11-14
Substance
LEVONORGESTREL
Active strength
1.5 mg/1
Pharmacologic classes
Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5W7SIA7YZWLEVONORGESTREL797-63-7LEVONORGESTREL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-892-57586020892571 BLISTER PACK in 1 CARTON (58602-892-57) / 1 TABLET in 1 BLISTER PACK1 blister pack2022-11-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ITHAPPENZ TM MORNING AFTER (levonorgestrel tablet 1.5 mg)Aurohealth LLC | Aurobindo Pharma Limited2025-04-07Human OTC Drug Label3