testosterone

Product NDC
16714-967
11-digit product format
167140967
Labeler code
16714
Product ID
16714-967_4a345c32-af7e-4998-a0a9-e8f3adef95ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
Northstar Rx LLC
Application
ANDA204268
Marketing category
ANDA
Marketing start
2019-11-06
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
20 mg/1.25g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-967-01GM - Gram16714-967a4cd7124-96d2-4f18-8ee3-35a38463b55c12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-967TESTOSTERONE GEL [NORTHSTAR RX LLC]8Legacy NDC20240315_2d55b825-8eab-4091-bdf2-9c52d111b8eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-967-01167140967011 BOTTLE, PUMP in 1 CARTON (16714-967-01) > 88 g in 1 BOTTLE, PUMP2019-11-060000-00-00NoNoCurrent