Depo-Testosterone

Product NDC
0009-0347
11-digit product format
000090347
Labeler code
0009
Product ID
0009-0347_6f9d26ce-7369-4283-97b0-fa06f187ac9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Pharmacia & Upjohn Company LLC
Application
ANDA085635
Marketing category
ANDA
Marketing start
1979-07-25
Substance
TESTOSTERONE CYPIONATE
Active strength
100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085635-001DEPO-TESTOSTERONETESTOSTERONE CYPIONATE50MG/MLINJECTABLE / INJECTIONApproved before 1982
A085635-002DEPO-TESTOSTERONETESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982
A085635-003DEPO-TESTOSTERONETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A085635-002AO
A085635-003AO

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085635-002AO1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085635-003AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085635-002AO131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085635-003AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085635-002AO16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085635-003AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085635-002AO1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085635-003AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085635-002AO1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085635-003AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085635-002AO103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085635-003AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085635-002AO12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085635-003AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085635-002AO15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085635-003AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085635-002AO1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085635-003AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085635-002AO1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085635-003AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085635-002AO179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085635-003AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085635-002AO1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085635-003AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085635-002AO11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085635-003AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085635-002AO18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A085635-003AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085635-002AO15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085635-003AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085635-002AO15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A085635-003AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085635-002AO14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A085635-003AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085635-002AO174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A085635-003AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085635-002AO1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A085635-003AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085635-002AO1782e0a99824c…
2021-12-28 21:50 UTC2021-12A085635-003AO1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLCcfbb53d4-b868-4a28-8436-f9112eb01c392025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085635
application number: ANDA085635
ndc (product): 0009-0347
Depo-TestosteroneTESTOSTERONE CYPIONATEAsclemed USA, Inc.2f72be32-ede6-44d9-88a0-0653b53a3e472025-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085635
application number: ANDA085635
Testosterone CypionateTESTOSTERONE CYPIONATEHospira, Inc.6909596e-4bf7-4e11-8029-b89740a30aec2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085635
application number: ANDA085635
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLC735b5bf3-4464-412c-a072-1bd02f2e53802025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085635
application number: ANDA085635

Additional Listing Data#

Finished product
Yes
Brand name base
Depo-Testosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M0XW1UBI14Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835829Internal RxNorm lookup
835831Internal RxNorm lookup
835840Internal RxNorm lookup
835842Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfbb53d4-b868-4a28-8436-f9112eb01c39Available on FDA.report

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
0009-0347-02Depo-Testosterone10 mL in 1 VIALINJECTION, SOLUTION1025
0009-0347-02Depo-Testosterone1 in 1 CARTONINJECTION, SOLUTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0347-02ML - Milliliter0009-03477e40e613-ff76-4cfa-b53e-a068affeb55212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0347DEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]21Current NDC, Legacy NDC, 2 package rows20240112_cfbb53d4-b868-4a28-8436-f9112eb01c39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835831Depo-Testosterone 100 MG/ML Injectable SolutionPSNcfbb53d4-b868-4a28-8436-f9112eb01c3925
835842Depo-Testosterone 200 MG/ML Injectable SolutionPSNcfbb53d4-b868-4a28-8436-f9112eb01c3925
835829testosterone cypionate 100 MG/ML Injectable SolutionPSNcfbb53d4-b868-4a28-8436-f9112eb01c3925
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNcfbb53d4-b868-4a28-8436-f9112eb01c3925
835831testosterone cypionate 100 MG/ML Injectable Solution [Depo-testosterone]SBDcfbb53d4-b868-4a28-8436-f9112eb01c3925
835842testosterone cypionate 200 MG/ML Injectable Solution [Depo-testosterone]SBDcfbb53d4-b868-4a28-8436-f9112eb01c3925
835829testosterone cypionate 100 MG/ML Injectable SolutionSCDcfbb53d4-b868-4a28-8436-f9112eb01c3925
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDcfbb53d4-b868-4a28-8436-f9112eb01c3925
835831Depo-testosterone 100 MG/ML Injectable SolutionSYcfbb53d4-b868-4a28-8436-f9112eb01c3925
835842Depo-testosterone 200 MG/ML Injectable SolutionSYcfbb53d4-b868-4a28-8436-f9112eb01c3925
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSYcfbb53d4-b868-4a28-8436-f9112eb01c3925
835831Depo-Testosterone 100 MG/ML Injectable SolutionPSN2f72be32-ede6-44d9-88a0-0653b53a3e472
835829testosterone cypionate 100 MG/ML Injectable SolutionPSN2f72be32-ede6-44d9-88a0-0653b53a3e472
835831testosterone cypionate 100 MG/ML Injectable Solution [Depo-testosterone]SBD2f72be32-ede6-44d9-88a0-0653b53a3e472
835829testosterone cypionate 100 MG/ML Injectable SolutionSCD2f72be32-ede6-44d9-88a0-0653b53a3e472
835831Depo-testosterone 100 MG/ML Injectable SolutionSY2f72be32-ede6-44d9-88a0-0653b53a3e472
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSY2f72be32-ede6-44d9-88a0-0653b53a3e472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0347-02000090347021 VIAL in 1 CARTON (0009-0347-02) / 10 mL in 1 VIAL1 vial1979-07-250000-00-00NoNoCurrent