FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
0143-9659
11-digit product format
001439659
Labeler code
0143
Product ID
0143-9659_918a0b71-0313-4fae-9e15-e2858c7f44da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091244
Marketing category
ANDA
Marketing start
2012-05-01
Substance
TESTOSTERONE CYPIONATE
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 Cypionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM0XW1UBI14
Rxcui835840, 2047882

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9659-01Testosterone Cypionate1 mL in 1 VIALINJECTION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9659-01ML - Milliliter0143-9659e11a689a-dc84-4b98-b7cc-6045bd1724eb12016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION [WEST-WARD PHARMACEUTICALS CORP]12
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION [WEST-WARD PHARMACEUTICALS CORP]12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION [WEST-WARD PHARMACEUTICALS CORP]12
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION [WEST-WARD PHARMACEUTICALS CORP]12
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTESTOSTERONE CYPIONATE INJECTION [WEST-WARD PHARMACEUTICALS CORP]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9659TESTOSTERONE CYPIONATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 1 package rows20220316_f60c5520-b336-44a2-95d5-f274939fa595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNf60c5520-b336-44a2-95d5-f274939fa59520
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNf60c5520-b336-44a2-95d5-f274939fa59520
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDf60c5520-b336-44a2-95d5-f274939fa59520
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDf60c5520-b336-44a2-95d5-f274939fa59520
2047882testosterone cypionate 200 MG per 1 ML InjectionSYf60c5520-b336-44a2-95d5-f274939fa59520
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN2db0a398-5512-431c-a952-b0290d4fe2d92
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD2db0a398-5512-431c-a952-b0290d4fe2d92
2047882testosterone cypionate 200 MG per 1 ML InjectionSY2db0a398-5512-431c-a952-b0290d4fe2d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9659-01001439659011 mL in 1 VIAL (0143-9659-01) 1 ml2012-05-010000-00-00NoNoCurrent