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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-6562DDiscontinued by firm2026-08-17
excluded packagepackage0409-65620409-6562-02DDiscontinued by firm2026-08-17
excluded packagepackage0409-65620409-6562-22DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-6562-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-6562-22d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-6562-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-6562-22f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A085635-001DEPO-TESTOSTERONE50MG/MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A085635-002DEPO-TESTOSTERONE100MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A085635-003DEPO-TESTOSTERONE200MG/MLINJECTABLE / INJECTIONAORLD, RS, Approved before 1982caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A085635-002AO1caaa826d4ba7…
2026-08-18 06:07:402026-07A085635-003AO1caaa826d4ba7…
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…

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 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835829Internal RxNorm lookup
835840Internal RxNorm lookup
2047882Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6909596e-4bf7-4e11-8029-b89740a30aecAvailable 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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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
ndc (product): 0409-6562
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLC735b5bf3-4464-412c-a072-1bd02f2e53802025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085635
application number: ANDA085635

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