FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
69097-802
11-digit product format
690970802
Labeler code
69097
Product ID
69097-802_5a71d184-5faa-444f-8d00-2f2531f342db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Cipla USA Inc.
Application
ANDA091244
Marketing category
ANDA
Marketing start
2019-03-26
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
69097-802-32Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION15
69097-802-32Testosterone Cypionate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION15
69097-802-37Testosterone Cypionate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION105
69097-802-37Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-802-32ML - Milliliter69097-8022f7f4081-8269-44d8-8718-c16978b992a812019-04-11
69097-802-37ML - Milliliter69097-80289ba2a7f-13bc-49f2-b1ee-f6ec0d7d6a0b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-802TESTOSTERONE CYPIONATE INJECTION, SOLUTION [CIPLA USA INC.]4Current NDC, Legacy NDC, 4 package rows20250523_b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
2047882testosterone cypionate 200 MG per 1 ML InjectionSYb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN9d0a1923-be39-41d9-8183-706b227f615c1
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN4bc98c02-6f63-440e-b3ce-89682ade81f61
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN9d0a1923-be39-41d9-8183-706b227f615c1
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD9d0a1923-be39-41d9-8183-706b227f615c1
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD4bc98c02-6f63-440e-b3ce-89682ade81f61
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD9d0a1923-be39-41d9-8183-706b227f615c1
2047882testosterone cypionate 200 MG per 1 ML InjectionSY9d0a1923-be39-41d9-8183-706b227f615c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-802-32690970802321 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS2019-03-260000-00-00NoNoCurrent
69097-802-37690970802371 VIAL, GLASS in 1 CARTON (69097-802-37) / 10 mL in 1 VIAL, GLASS2019-03-260000-00-00NoNoCurrent