FDA.reportPublic FDA data

TESTOSTERONE ENANTHATE

Product NDC
0143-9750
11-digit product format
001439750
Labeler code
0143
Product ID
0143-9750_8d67aa07-833f-4be7-8a7e-e49e19f49949
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TESTOSTERONE ENANTHATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091120
Marketing category
ANDA
Marketing start
2012-09-18
Substance
TESTOSTERONE ENANTHATE
Active strength
200 mg/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TESTOSTERONE ENANTHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE ENANTHATE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7Z6522T8N9
Rxcui835809

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
0143-9750-01TESTOSTERONE ENANTHATE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9750-01ML - Milliliter0143-9750b5dc1422-e7ae-407b-ac6a-cedb8d73376312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE ENANTHATEACTIVE INGREDIENT7Z6522T8N9TESTOSTERONE ENANTHATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]6
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE ENANTHATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]6
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCTESTOSTERONE ENANTHATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]6
SESAME OILINACTIVE INGREDIENTQX10HYY4QVTESTOSTERONE ENANTHATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9750TESTOSTERONE ENANTHATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 1 package rows20211116_e89d6458-428c-4256-97a3-f1fa851293c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835809testosterone enanthate 200 MG/ML Injectable SolutionPSNe89d6458-428c-4256-97a3-f1fa851293c110
835809testosterone enanthate 200 MG/ML Injectable SolutionSCDe89d6458-428c-4256-97a3-f1fa851293c110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9750-01001439750015 mL in 1 VIAL, MULTI-DOSE (0143-9750-01) 5 ml2012-09-180000-00-00NoNoCurrent