PostDay One-Step

Product NDC
69953-618
11-digit product format
699530618
Labeler code
69953
Product ID
69953-618_0aab0d9b-3db7-7c71-e063-6394a90a9c89
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Rapha Pharmaceuticals, Inc.
Application
ANDA205329
Marketing category
ANDA
Marketing start
2023-11-21
Substance
LEVONORGESTREL
Active strength
1.5 mg/1.5mg
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
69953-618-43699530618431 BLISTER PACK in 1 CARTON (69953-618-43) / 1 mg in 1 BLISTER PACK1 blister pack2023-11-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PostDay One-Step - Rapha Pharmaceuticals, Inc.Rapha Pharmaceuticals, Inc.2023-11-21HUMAN OTC DRUG LABEL3