TESTOSTERONE

Product NDC
71589-013
11-digit product format
715890013
Labeler code
71589
Product ID
71589-013_f37d0249-0de6-4657-bf15-fbf63ccd27b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TESTOSTERONE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Aleor Dermaceuticals Limited
Application
ANDA212882
Marketing category
ANDA
Marketing start
2021-07-01
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
30 mg/1.5mL
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71589-013-112025-03-10C16284748780-1f386c64a-2c14-0266-e053-dadaa90a7c1a9fe3a833-d9eb-4559-9b9e-1379ec4487a0
71589-013-112023-01-30C16284748780-1f386c64a-2c14-0266-e053-dadaa90a7c1a9fe3a833-d9eb-4559-9b9e-1379ec4487a0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71589-013-11715890013111 BOTTLE, WITH APPLICATOR in 1 CARTON (71589-013-11) > 110 mL in 1 BOTTLE, WITH APPLICATOR2021-07-010000-00-00NoNoCurrent