FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
0574-0827
11-digit product format
005740827
Labeler code
0574
Product ID
0574-0827_aa3130c8-5ef7-4fcc-8478-7c2dd9973fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Padagis US LLC
Application
ANDA091244
Marketing category
ANDA
Marketing start
2014-05-01
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
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
0574-0827-01Testosterone Cypionate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION16
0574-0827-01Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION16
0574-0827-10Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION16
0574-0827-10Testosterone Cypionate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0827-01ML - Milliliter0574-082792ce9852-3f23-4ce4-aa99-d886f87d8d1412019-04-11
0574-0827-10ML - Milliliter0574-0827fa0cd9c9-0260-4c39-a341-24f7d6854aa912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]1
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0827TESTOSTERONE CYPIONATE INJECTION, SOLUTION [PADAGIS US LLC]6Current NDC, Legacy NDC, 4 package rows20241208_e3e2da65-4b2a-4210-a6ff-cc08c8567381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN3b0c61de-8cfa-4f76-b07c-0d3b7704b642104
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD3b0c61de-8cfa-4f76-b07c-0d3b7704b642104
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b101
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b101
2047882testosterone cypionate 200 MG per 1 ML InjectionSY1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b101
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN327b4357-6948-4cd6-ad6c-e463ab8600ad100
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD327b4357-6948-4cd6-ad6c-e463ab8600ad100
2047882testosterone cypionate 200 MG per 1 ML InjectionSY327b4357-6948-4cd6-ad6c-e463ab8600ad100
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNe3e2da65-4b2a-4210-a6ff-cc08c85673816
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNe3e2da65-4b2a-4210-a6ff-cc08c85673816
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDe3e2da65-4b2a-4210-a6ff-cc08c85673816
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDe3e2da65-4b2a-4210-a6ff-cc08c85673816
2047882testosterone cypionate 200 MG per 1 ML InjectionSYe3e2da65-4b2a-4210-a6ff-cc08c85673816
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN47df0787-af81-43ca-bd67-1b5d127ff3c35
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD47df0787-af81-43ca-bd67-1b5d127ff3c35
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN8699c6cb-fede-43ea-ad5e-817700fa7a821
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD8699c6cb-fede-43ea-ad5e-817700fa7a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0827-01005740827011 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS2019-03-040000-00-00NoNoCurrent
0574-0827-10005740827101 VIAL, GLASS in 1 CARTON (0574-0827-10) / 10 mL in 1 VIAL, GLASS2014-05-010000-00-00NoNoCurrent