Testosterone

Product NDC: 0591-2363
Requested package NDC: 0591-2363-60
11-digit product format: 005912363
Labeler code: 0591
Product ID: 0591-2363_a4201616-9b08-42e3-b0de-bf8354152d3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL, METERED
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA204571
Marketing category: ANDA
Marketing start: 2015-06-01
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 10 mg/.5g
Pharmacologic classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0591-2363	0591-2363-60	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204571-001	TESTOSTERONE	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RS	2015-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204571-001	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB		2015-08-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204571-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204571-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204571-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204571-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204571-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204571-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204571-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204571-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204571-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204571-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204571-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204571-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204571-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A204571-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204571-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204571-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204571-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204571-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204571-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204571-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204571-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204571-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204571-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204571-001	AB	1	`cb3db0bc1861…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
ed2e617f-f28a-1df1-f9fc-c79702f31271	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2363-60	GM - Gram	0591-2363	c88954f3-c168-4d9c-9336-ec6bfc8a31eb	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2363	TESTOSTERONE GEL, METERED [ACTAVIS PHARMA, INC.]	15	Legacy NDC	20250312_415057d5-8ed3-42dd-9637-05145c84a9c2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3XMK78S47O	TESTOSTERONE	58-22-0	TESTOSTERONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2363-60	00591236360	1 CANISTER in 1 CARTON (0591-2363-60) > 60 g in 1 CANISTER	1 canister	2015-06-01	0000-00-00	No	No	Current