Depo-Testosterone

Product NDC: 76420-425
11-digit product format: 764200425
Labeler code: 76420
Product ID: 76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone cypionate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Asclemed USA, Inc.
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A085635-001	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982
A085635-002	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982
A085635-003	DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-002	DEPO-TESTOSTERONE	100MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-003	DEPO-TESTOSTERONE	200MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085635-001	DEPO-TESTOSTERONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A085635-002	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085635-003	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085635-002	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085635-003	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-002	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085635-003	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085635-002	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085635-003	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-002	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085635-003	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-002	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085635-003	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-002	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085635-003	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-002	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085635-003	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-002	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085635-003	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-002	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085635-003	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085635-002	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085635-003	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-002	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085635-003	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-002	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085635-003	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085635-002	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085635-003	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085635-002	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085635-003	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085635-002	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085635-003	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085635-002	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085635-003	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085635-002	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085635-003	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085635-002	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085635-003	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085635-002	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A085635-003	AO	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE CYPIONATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M0XW1UBI14	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2f72be32-ede6-44d9-88a0-0653b53a3e47	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2db4fc38-a116-b0ab-3dae-57df54e5f212	Product name	2	20250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3	Product name	5	20240422
7d55b53c-798b-47ae-992b-3921493a8303	Product name	1	20230322
8d753fd6-75b2-4f12-bcbf-339392960afa	Product name	1	20230303
4fbda828-a5be-46fe-83ec-a88da4359919	Product name	1	20230104
93cc9bee-8bdc-273d-ec7f-c2c52535317a	Product name	7	20210902
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	5	20210601
f4f0889f-ee8b-471f-9a37-02a035280637	Product name	1	20200122
09e1afd3-f431-4380-82c5-438884c25615	Product name	1	20190111
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	3	20171212
502efed8-01a5-ef6a-61c6-fe8302b6e26b	Product name	2	20171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2	Product name	1	20171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68	Product name	2	20171113
96bdf4b3-71cd-433d-9723-89e50f852992	Product name	1	20150810
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ed2e617f-f28a-1df1-f9fc-c79702f31271	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-425-10	Depo-Testosterone	1 in 1 CARTON	INJECTION, SOLUTION	1		2
76420-425-10	Depo-Testosterone	10 mL in 1 VIAL	INJECTION, SOLUTION	10		2

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	cfbb53d4-b868-4a28-8436-f9112eb01c39	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635
Depo-Testosterone	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	2f72be32-ede6-44d9-88a0-0653b53a3e47	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635 ndc (product): 76420-425
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hospira, Inc.	6909596e-4bf7-4e11-8029-b89740a30aec	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	735b5bf3-4464-412c-a072-1bd02f2e5380	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085635 application number: ANDA085635

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M0XW1UBI14	TESTOSTERONE CYPIONATE	58-20-8	TESTOSTERONE CYPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835831	Depo-Testosterone 100 MG/ML Injectable Solution	PSN	2f72be32-ede6-44d9-88a0-0653b53a3e47	2
835829	testosterone cypionate 100 MG/ML Injectable Solution	PSN	2f72be32-ede6-44d9-88a0-0653b53a3e47	2
835831	testosterone cypionate 100 MG/ML Injectable Solution [Depo-testosterone]	SBD	2f72be32-ede6-44d9-88a0-0653b53a3e47	2
835829	testosterone cypionate 100 MG/ML Injectable Solution	SCD	2f72be32-ede6-44d9-88a0-0653b53a3e47	2
835831	Depo-testosterone 100 MG/ML Injectable Solution	SY	2f72be32-ede6-44d9-88a0-0653b53a3e47	2
835829	testosterone cypionate 1000 MG per 10 ML Injectable Solution	SY	2f72be32-ede6-44d9-88a0-0653b53a3e47	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-425-10	76420042510	1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIAL	1 vial	2025-08-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Depo ® -Testosterone testosterone cypionate injection, USP CIII	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-08-27	HUMAN PRESCRIPTION DRUG LABEL	2