FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
50090-4920
11-digit product format
500904920
Labeler code
50090
Product ID
50090-4920_ea02d57d-1787-42ff-bf4e-7dcaf96f5c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4920-02023-12-05C16284748780-1f386c649-f151-0266-e053-dadaa90a7c1aTestosterone Cypionate Injection, USP CIII Rx Only
50090-4920-02023-01-30C16284748780-1f386c649-f151-0266-e053-dadaa90a7c1aTestosterone Cypionate Injection, USP CIII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4920-0Testosterone Cypionate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION105
50090-4920-0Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4920-0ML - Milliliter50090-4920cae91b78-65b0-4d6a-b472-14b5fb8a4ba612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4920TESTOSTERONE CYPIONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240731_47df0787-af81-43ca-bd67-1b5d127ff3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN47df0787-af81-43ca-bd67-1b5d127ff3c35
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD47df0787-af81-43ca-bd67-1b5d127ff3c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4920-0500904920001 VIAL, GLASS in 1 CARTON (50090-4920-0) / 10 mL in 1 VIAL, GLASS2020-02-190000-00-00NoNoCurrent