Testosterone

Product NDC: 0591-2926
11-digit product format: 005912926
Labeler code: 0591
Product ID: 0591-2926_b63936d3-2d0c-4a45-8096-2d5c672e3819
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone
Dosage form: GEL
Route: TRANSDERMAL
Labeler: Actavis Pharma, Inc.
Application: ANDA204570
Marketing category: ANDA
Marketing start: 2021-02-12
Substance: TESTOSTERONE
Active strength: 16.2 mg/g
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 1.

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	Approval date
A204570-001	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10
A204570-002	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17
A204570-003	TESTOSTERONE	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204570-001	AB
A204570-002	AB2
A204570-003	AB2

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 · 109 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
2026-02-19 14:30 UTC	2026-02	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204570-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204570-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204570-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204570-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE	16.2 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3XMK78S47O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1597076	Internal RxNorm lookup
1597120	Internal RxNorm lookup
1597126	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
4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	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
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
0591-2926-25	Testosterone	2.5 g in 1 PACKET	GEL	2.5		11
0591-2926-30	Testosterone	30 in 1 CARTON	GEL	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2926-25	GM - Gram	0591-2926	f6afcb25-981a-49fc-990a-3b6bd86f2dc7	1	2021-03-02
0591-2926-30	GM - Gram	0591-2926	c1344ee2-c0f0-4362-90eb-151f8a888077	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2926	TESTOSTERONE GEL [ACTAVIS PHARMA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20210213_4f3c2c0a-7dab-4b50-9cae-869c3c2a8498.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	TESTOSTERONE	Actavis Pharma, Inc.	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204570 application number: ANDA204570 ndc (product): 0591-2926

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1597076	testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT	PSN	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597120	testosterone 1.62 % (20.25MG / 1.25GM) Transdermal Gel	PSN	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597126	testosterone 1.62 % (40.5MG / 2.5GM) Transdermal Gel	PSN	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597120	1250 MG testosterone 0.0162 MG/MG Topical Gel	SCD	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597126	2500 MG testosterone 0.0162 MG/MG Topical Gel	SCD	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597076	60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel	SCD	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597076	testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT	SY	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597120	testosterone 1.62 % Transdermal Gel, 1.25 GM	SY	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11
1597126	testosterone 1.62 % Transdermal Gel, 2.5 GM	SY	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2926-25	00591292625	2.5 g in 1 PACKET	2.5 g					Historical
0591-2926-30	00591292630	30 PACKET in 1 CARTON (0591-2926-30) / 2.5 g in 1 PACKET (0591-2926-25)	30 packet	2021-02-12	0000-00-00	No	No	Current