Testosterone Cypionate

Product NDC: 0517-1830
11-digit product format: 005171830
Labeler code: 0517
Product ID: 0517-1830_110449a6-1353-41e1-a41e-cb4cb4f0a5ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone Cypionate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: American Regent, Inc.
Application: ANDA207742
Marketing category: ANDA
Marketing start: 2019-07-19
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0517-1830		D	Discontinued by firm		2026-08-17
excluded package	package	0517-1830	0517-1830-01	D	Discontinued by firm		2026-08-17

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
A207742-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207742-001	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	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`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	A207742-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207742-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207742-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207742-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207742-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207742-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207742-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207742-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207742-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207742-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207742-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207742-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207742-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207742-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207742-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207742-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207742-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207742-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207742-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207742-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207742-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207742-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207742-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207742-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207742-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207742-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207742-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207742-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207742-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207742-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207742-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207742-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207742-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207742-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207742-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207742-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207742-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207742-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207742-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207742-001	AO	1	`e64feba35796…`

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
0517-1830-01	Testosterone Cypionate	1 mL in 1 VIAL	INJECTION, SOLUTION	1		14
0517-1830-01	Testosterone Cypionate	1 in 1 BOX	INJECTION, SOLUTION	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-1830-01	ML - Milliliter	0517-1830	e6502c6a-b497-4a24-b15d-780d5995d0d0	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-1830	TESTOSTERONE CYPIONATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20221205_08f88e0e-d9a4-4a03-9286-46d9bf9a363e.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone cypionate	TESTOSTERONE CYPIONATE	Alvogen Inc.	ed65346b-31bc-f872-516d-78d5ab70229e	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals, Inc.	346604c7-22d0-60c5-e063-6394a90abf0b	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals,Inc.	335ff614-15ec-0792-e063-6294a90a2f08	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742
testosterone cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	ffb1ae64-9026-44c9-83a0-32058957ecc9	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742

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	08f88e0e-d9a4-4a03-9286-46d9bf9a363e	14
2047882	1 ML testosterone cypionate 200 MG/ML Injection	SCD	08f88e0e-d9a4-4a03-9286-46d9bf9a363e	14
2047882	testosterone cypionate 200 MG per 1 ML Injection	SY	08f88e0e-d9a4-4a03-9286-46d9bf9a363e	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-1830-01	00517183001	1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL	1 vial	2019-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Testosterone Cypionate Injection, USP CIII Rx Only	American Regent, Inc.	2019-06-17	HUMAN PRESCRIPTION DRUG LABEL	14