FDA.reportPublic FDA data

Testosterone

Product NDC
64380-151
11-digit product format
643800151
Labeler code
64380
Product ID
64380-151_6d50f17e-4607-458a-882b-620daa3b58a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Strides Pharma Science Limited
Application
ANDA076744
Marketing category
ANDA
Marketing start
2022-06-27
Substance
TESTOSTERONE
Active strength
25 mg/2.5g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Testosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE25 mg/2.5g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1597123, 1597129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-151-01Testosterone2.5 g in 1 DOSE PACKGEL2.56
64380-151-02Testosterone30 in 1 CARTONGEL306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-151-01GM - Gram64380-15159a9c0c0-5633-41d3-8c63-6a7f876a4c2d12024-07-12
64380-151-02GM - Gram64380-15148d5ced3-1106-4569-8189-8634e116faa412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-151TESTOSTERONE GEL [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, Legacy NDC, 2 package rows20240627_ee54c393-bcfe-4a52-b7b3-1da8750f35d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597123testosterone 1 % (25 MG / 2.5 GM) Transdermal GelPSNee54c393-bcfe-4a52-b7b3-1da8750f35d96
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSNee54c393-bcfe-4a52-b7b3-1da8750f35d96
15971232500 MG testosterone 0.01 MG/MG Topical GelSCDee54c393-bcfe-4a52-b7b3-1da8750f35d96
15971295000 MG testosterone 0.01 MG/MG Topical GelSCDee54c393-bcfe-4a52-b7b3-1da8750f35d96
1597123testosterone 1 % Transdermal Gel, 2.5 GMSYee54c393-bcfe-4a52-b7b3-1da8750f35d96
1597129testosterone 50 MG Transdermal Gel, 5 GMSYee54c393-bcfe-4a52-b7b3-1da8750f35d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-151-01643800151012.5 g in 1 DOSE PACK2.5 gHistorical
64380-151-026438001510230 DOSE PACK in 1 CARTON (64380-151-02) / 2.5 g in 1 DOSE PACK (64380-151-01) 30 dose pack2022-06-270000-00-00NoNoCurrent