Estradiol Vaginal

Product NDC
0115-1518
11-digit product format
001151518
Labeler code
0115
Product ID
0115-1518_af097442-3a07-4842-901d-151d63951f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
CREAM
Route
VAGINAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA210194
Marketing category
ANDA
Marketing start
2018-03-14
Marketing end
2022-12-31
Substance
ESTRADIOL
Active strength
0 mg/g
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1518-662021-12-08C16284748780-1ba0f9c33-45e7-a910-e053-dadaa90a0b85b69cacf1-3265-4df7-8d83-df4b4a43a103
0115-1518-662021-01-29C16284748780-1ba0f9c33-45e7-a910-e053-dadaa90a0b85b69cacf1-3265-4df7-8d83-df4b4a43a103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1518-66GM - Gram0115-15189c9a4d57-25af-46f3-94c6-76fa042c5a9212018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1518-66001151518661 TUBE in 1 CARTON (0115-1518-66) > 42.5 g in 1 TUBE1 tube2018-03-142022-12-31NoNoCurrent