Testosterone Cypionate

Product NDC: 50090-4446
Requested package NDC: 50090-4446-0
11-digit product format: 500904446
Labeler code: 50090
Product ID: 50090-4446_b84533bd-d44d-4dad-94c3-6f6aabd0e66a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone Cypionate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: A-S Medication Solutions
Application: ANDA201720
Marketing category: ANDA
Marketing start: 2013-06-17
Marketing end: 0000-00-00
Substance: TESTOSTERONE CYPIONATE
Active strength: 200 mg/mL
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4446	50090-4446-0	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201720-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION			2013-06-03
A201720-002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION			2013-06-03

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 3 · 84 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	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION		2013-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		2013-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201720-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201720-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2013-06-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201720-002	AO	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A201720-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201720-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201720-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201720-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201720-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201720-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201720-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201720-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201720-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201720-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201720-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201720-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201720-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201720-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201720-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201720-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201720-001	AO	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201720-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-001	AO	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201720-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201720-001	AO	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201720-002	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201720-001	AO	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201720-002	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201720-001	AO	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201720-002	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201720-001	AO	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201720-002	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201720-001	AO	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201720-002	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201720-001	AO	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201720-002	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-001	AO	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201720-002	AO	1	`6a51e52b5d6a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4446-0	2023-01-30	C162847	48780-1	f386c649-b1a4-0266-e053-dadaa90a7c1a	Testosterone Cypionate Injection C-III

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4446-0	Testosterone Cypionate	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		4
50090-4446-0	Testosterone Cypionate	1 in 1 CARTON	INJECTION, SOLUTION	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4446	TESTOSTERONE CYPIONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20210418_3602f307-19c3-4f09-a3e3-98c10a19ec28.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Sun Pharmaceutical Industries, Inc.	3653a602-4551-4e6c-84a7-31861f5dc482	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201720 application number: ANDA201720

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
835840	testosterone cypionate 200 MG/ML Injectable Solution	PSN	3602f307-19c3-4f09-a3e3-98c10a19ec28	4
835840	testosterone cypionate 200 MG/ML Injectable Solution	SCD	3602f307-19c3-4f09-a3e3-98c10a19ec28	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4446-0	50090444600	1 VIAL, MULTI-DOSE in 1 CARTON (50090-4446-0) > 10 mL in 1 VIAL, MULTI-DOSE	2019-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Testosterone Cypionate Injection C-III	A-S Medication Solutions	2021-04-16	Human Prescription Drug Label	4