Testosterone Cypionate

Product NDC
0409-6562
11-digit product format
004096562
Labeler code
0409
Product ID
0409-6562_e56a4a35-f147-4f61-b47c-37aea1e6e558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Hospira, Inc.
Application
ANDA085635
Marketing category
ANDA
Marketing start
2016-08-01
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
Rxcui835829, 835840, 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
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6562-01Testosterone Cypionate1 mL in 1 VIALINJECTION, SOLUTION110
0409-6562-01Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION110
0409-6562-20Testosterone Cypionate10 mL in 1 VIALINJECTION, SOLUTION1010
0409-6562-20Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6562-02ML - Milliliter0409-6562f2c2eb43-0dd6-479d-8d59-94a188c2f1c812018-02-20
0409-6562-22ML - Milliliter0409-656294373ad6-8d9a-43c4-bb8d-8bc45ccec2b012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6562TESTOSTERONE CYPIONATE INJECTION, SOLUTION [HOSPIRA, INC.]8Current NDC, Legacy NDC, 4 package rows20200819_6909596e-4bf7-4e11-8029-b89740a30aec.zip
0409-6562TESTOSTERONE CYPIONATE INJECTION, SOLUTION [HOSPIRA, INC.]3Current NDC, Legacy NDC20200819_c5efc1ed-dd50-48fe-81b6-4d691a178630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835829testosterone cypionate 100 MG/ML Injectable SolutionPSN6909596e-4bf7-4e11-8029-b89740a30aec10
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN6909596e-4bf7-4e11-8029-b89740a30aec10
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN6909596e-4bf7-4e11-8029-b89740a30aec10
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD6909596e-4bf7-4e11-8029-b89740a30aec10
835829testosterone cypionate 100 MG/ML Injectable SolutionSCD6909596e-4bf7-4e11-8029-b89740a30aec10
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD6909596e-4bf7-4e11-8029-b89740a30aec10
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSY6909596e-4bf7-4e11-8029-b89740a30aec10
2047882testosterone cypionate 200 MG per 1 ML InjectionSY6909596e-4bf7-4e11-8029-b89740a30aec10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6562-01004096562011 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL1 vial2016-08-010000-00-00NoNoCurrent
0409-6562-02004096562021 VIAL in 1 CARTON (0409-6562-02) > 1 mL in 1 VIAL1 vial2018-01-170000-00-00NoNoCurrent
0409-6562-20004096562201 VIAL in 1 CARTON (0409-6562-20) / 10 mL in 1 VIAL1 vial2016-08-010000-00-00NoNoCurrent
0409-6562-22004096562221 VIAL in 1 CARTON (0409-6562-22) > 10 mL in 1 VIAL1 vial2018-01-170000-00-00NoNoCurrent