My Way

Product NDC
57297-852
11-digit product format
572970852
Labeler code
57297
Product ID
57297-852_415e14cb-df0a-456a-b2b1-8dfcd5f8ef2d
Type
HUMAN OTC DRUG
Nonproprietary name
levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
LUPIN LIMITED
Application
ANDA201446
Marketing category
ANDA
Marketing start
2017-04-25
Marketing end
0000-00-00
Substance
LEVONORGESTREL
Active strength
2 mg/1
Pharmacologic classes
Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57297-852-11572970852111 BLISTER PACK in 1 CARTON (57297-852-11) > 1 TABLET in 1 BLISTER PACK1 blister pack2017-04-250000-00-00NoNoCurrent