Testosterone Cypionate

Product NDC: 71335-2838
11-digit product format: 713352838
Labeler code: 71335
Product ID: 71335-2838_56126ce3-fb56-45b9-8fed-e9cafecab269
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone Cypionate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Bryant Ranch Prepack
Application: ANDA091244
Marketing category: ANDA
Marketing start: 2014-05-01
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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091244-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2012-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091244-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A091244-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	AO	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE CYPIONATE	200 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2047882	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
1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	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
71335-2838-1	Testosterone Cypionate	1 in 1 CARTON	INJECTION, SOLUTION	1		101
71335-2838-1	Testosterone Cypionate	1 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	1		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2838-1	ML - Milliliter	71335-2838	dcf9fe93-d8b8-47ba-8fac-3925ad2bd6c9	1	2025-12-16

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	ASCLEMED USA INC.	4efcb0be-a19b-4c6b-8a42-cd52a40d095b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	ad65b1ec-433e-4524-924e-ebad09762126	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	327b4357-6948-4cd6-ad6c-e463ab8600ad	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 71335-2838
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Cipla USA Inc.	b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	f60c5520-b336-44a2-95d5-f274939fa595	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	5ca67491-4b30-4a47-af0a-be250215d1f0	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	47df0787-af81-43ca-bd67-1b5d127ff3c3	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	9d0a1923-be39-41d9-8183-706b227f615c	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	8699c6cb-fede-43ea-ad5e-817700fa7a82	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	3b0c61de-8cfa-4f76-b07c-0d3b7704b642	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Padagis US LLC	e3e2da65-4b2a-4210-a6ff-cc08c8567381	2021-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	6bb7d3cc-2b5a-4a48-858e-5421c68b6989	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	2db0a398-5512-431c-a952-b0290d4fe2d9	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244

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
2047882	testosterone cypionate 200 MG in 1 ML Injection	PSN	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	101
2047882	1 ML testosterone cypionate 200 MG/ML Injection	SCD	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	101
2047882	testosterone cypionate 200 MG per 1 ML Injection	SY	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2838-1	71335283801	1 VIAL, GLASS in 1 CARTON (71335-2838-1) / 1 mL in 1 VIAL, GLASS	2025-10-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Testosterone Cypionate Injection, USP CIII Rx Only	Bryant Ranch Prepack	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	101