FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
0574-0820
11-digit product format
005740820
Labeler code
0574
Product ID
0574-0820_7c28a0f7-0df7-4f96-a612-338500472112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Padagis US LLC
Application
ANDA040530
Marketing category
ANDA
Marketing start
2007-12-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0574-0820-01Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION123
0574-0820-01Testosterone Cypionate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION123
0574-0820-10Testosterone Cypionate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1023
0574-0820-10Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION123
0574-0820-01Testone CIK1 in 1 CARTONINJECTION, SOLUTION200 mg in 1mL11
0574-0820-01Testone CIK1 mL in 1 VIAL, GLASSINJECTION, SOLUTION1 mL200 mg in 1mL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0820-01ML - Milliliter0574-0820211d8584-9ec8-4608-90ca-7a5aa8b80b7d12012-07-24
0574-0820-10ML - Milliliter0574-0820af28b9d0-3aa1-458e-98c7-66621c053f7512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]13
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]13
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]13
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]13
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]13
Testosterone CypionateACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
TestosteroneACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Benzyl BenzoateINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Cotton SeedINACTIVE INGREDIENTDI0ZRJ0MXNTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
Isopropyl AlcoholACTIVE INGREDIENTND2M416302TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Testosterone CypionateACTIVE INGREDIENTM0XW1UBI14TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
TestosteroneACTIVE MOIETY3XMK78S47OTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Benzyl BenzoateINACTIVE INGREDIENTN863NB338GTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Cottonseed OilINACTIVE INGREDIENTH3E878020NTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0820TESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADAGIS US LLC]22Current NDC, Legacy NDC, 4 package rows20250524_4195516a-c8e6-457c-b805-43c9a3ca8b77.zip
0574-0820TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20240613_edcd5209-70db-4727-991e-3fdd185d9211.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN72cc2d2d-7807-46a6-a0ac-790a1f8dcaac100
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNb116d834-51f1-4b92-8e1e-a51dbd883c1f100
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN2eb9e2a9-75ec-4a5d-8131-0076c50708bb100
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD72cc2d2d-7807-46a6-a0ac-790a1f8dcaac100
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDb116d834-51f1-4b92-8e1e-a51dbd883c1f100
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD2eb9e2a9-75ec-4a5d-8131-0076c50708bb100
2047882testosterone cypionate 200 MG per 1 ML InjectionSY72cc2d2d-7807-46a6-a0ac-790a1f8dcaac100
2047882testosterone cypionate 200 MG per 1 ML InjectionSYb116d834-51f1-4b92-8e1e-a51dbd883c1f100
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN4195516a-c8e6-457c-b805-43c9a3ca8b7723
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN4195516a-c8e6-457c-b805-43c9a3ca8b7723
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD4195516a-c8e6-457c-b805-43c9a3ca8b7723
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD4195516a-c8e6-457c-b805-43c9a3ca8b7723
2047882testosterone cypionate 200 MG per 1 ML InjectionSY4195516a-c8e6-457c-b805-43c9a3ca8b7723
797544isopropyl alcohol 70 % Medicated PadPSNedcd5209-70db-4727-991e-3fdd185d921111
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNedcd5209-70db-4727-991e-3fdd185d921111
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNedcd5209-70db-4727-991e-3fdd185d921111
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDedcd5209-70db-4727-991e-3fdd185d921111
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Medicated PadSYedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Topical ClothSYedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Topical SwabSYedcd5209-70db-4727-991e-3fdd185d921111
2047882testosterone cypionate 200 MG per 1 ML InjectionSYedcd5209-70db-4727-991e-3fdd185d921111
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN2321a581-2e33-4233-a1d4-0711b90e3c5710
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD2321a581-2e33-4233-a1d4-0711b90e3c5710
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN108facca-c6d2-48fa-ba48-667c9498c61b2
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN108facca-c6d2-48fa-ba48-667c9498c61b2
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD108facca-c6d2-48fa-ba48-667c9498c61b2
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD108facca-c6d2-48fa-ba48-667c9498c61b2
2047882testosterone cypionate 200 MG per 1 ML InjectionSY108facca-c6d2-48fa-ba48-667c9498c61b2
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN54aee197-7c9c-479f-8a4d-a8d4d31f40c11
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD54aee197-7c9c-479f-8a4d-a8d4d31f40c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0820-01005740820011 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS2015-01-090000-00-00NoNoCurrent
0574-0820-10005740820101 VIAL, GLASS in 1 CARTON (0574-0820-10) / 10 mL in 1 VIAL, GLASS2014-12-160000-00-00NoNoCurrent