FDA.reportPublic FDA data

testosterone cypionate

Product NDC
72603-286
11-digit product format
726030286
Labeler code
72603
Product ID
72603-286_3ba42272-97f6-0e87-e063-6394a90a2d9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
NorthStar Rx LLC
Application
ANDA215351
Marketing category
ANDA
Marketing start
2024-11-01
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
Rxcui2047882

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
72603-286-01testosterone cypionate1 in 1 CARTONINJECTION, SOLUTION15
72603-286-01testosterone cypionate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-286-01ML - Milliliter72603-286e8b38ebd-b9f5-4d22-9937-141fd6132ddc12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-286TESTOSTERONE CYPIONATE INJECTION, SOLUTION [NORTHSTAR RX LLC]4Current NDC, 2 package rows20241102_9ced69c7-cd37-efb6-1bf9-e21c01e56f5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN9ced69c7-cd37-efb6-1bf9-e21c01e56f5b5
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD9ced69c7-cd37-efb6-1bf9-e21c01e56f5b5
2047882testosterone cypionate 200 MG per 1 ML InjectionSY9ced69c7-cd37-efb6-1bf9-e21c01e56f5b5
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN7df45a8d-7d6b-4776-85e3-529527574a4f3
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD7df45a8d-7d6b-4776-85e3-529527574a4f3
2047882testosterone cypionate 200 MG per 1 ML InjectionSY7df45a8d-7d6b-4776-85e3-529527574a4f3
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNe9d48af3-9514-4dc5-972c-0c1f2547e5c61
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDe9d48af3-9514-4dc5-972c-0c1f2547e5c61
2047882testosterone cypionate 200 MG per 1 ML InjectionSYe9d48af3-9514-4dc5-972c-0c1f2547e5c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-286-01726030286011 VIAL, SINGLE-DOSE in 1 CARTON (72603-286-01) / 1 mL in 1 VIAL, SINGLE-DOSE2024-11-01NoNoCurrent