Testosterone

Product NDC: 66993-951
11-digit product format: 669930951
Labeler code: 66993
Product ID: 66993-951_b50198b2-d959-48cd-883d-3e1d30f9374b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL
Route: TRANSDERMAL
Labeler: Prasco Laboratories
Application: NDA022309
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-05-19
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	RLD / RS	Approval date
N022309-001	ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29
N022309-002	ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07
N022309-003	ANDROGEL	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022309-001	AB
N022309-002	AB2
N022309-003	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022309-001	8466136	2026-10-12		Drug product	2013-06-24
N022309-001	8466137	2026-10-12	U-1103		2013-06-24
N022309-001	8466138	2026-10-12	U-1103		2013-06-24
N022309-001	8486925	2026-10-12		Drug product	2013-07-19
N022309-001	8729057	2026-10-12		Drug product
N022309-001	8741881	2026-10-12	U-1103		2014-06-25
N022309-001	8754070	2026-10-12		Drug product	2014-07-16
N022309-001	8759329	2026-10-12		Drug product	2014-07-09
N022309-002	8466136	2026-10-12		Drug product	2013-06-24
N022309-002	8466137	2026-10-12	U-1103		2013-06-24
N022309-002	8466138	2026-10-12	U-1103		2013-06-24
N022309-002	8486925	2026-10-12		Drug product	2013-07-19
N022309-002	8729057	2026-10-12		Drug product	2014-06-13
N022309-002	8741881	2026-10-12	U-1103		2014-06-25
N022309-002	8754070	2026-10-12		Drug product	2014-07-16
N022309-002	8759329	2026-10-12		Drug product	2014-07-09
N022309-003	8466136	2026-10-12		Drug product	2013-06-24
N022309-003	8466137	2026-10-12	U-1103		2013-06-24
N022309-003	8466138	2026-10-12	U-1103		2013-06-24
N022309-003	8486925	2026-10-12		Drug product	2013-07-19
N022309-003	8729057	2026-10-12		Drug product	2014-06-13
N022309-003	8741881	2026-10-12	U-1103		2014-06-25
N022309-003	8754070	2026-10-12		Drug product	2014-07-16
N022309-003	8759329	2026-10-12		Drug product	2014-07-09

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 4 · 123 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	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	N022309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022309-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022309-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022309-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022309-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022309-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022309-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022309-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022309-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022309-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022309-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022309-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022309-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022309-001	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022309-001	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8729057	2026-10-12		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8729057	2026-10-12		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8729057	2026-10-12		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466136	2026-10-12		Drug product	2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466137	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466138	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8486925	2026-10-12		Drug product	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8729057	2026-10-12		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8741881	2026-10-12	U-1103		2014-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8754070	2026-10-12		Drug product	2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8759329	2026-10-12		Drug product	2014-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466136	2026-10-12		Drug product	2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466137	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466138	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8486925	2026-10-12		Drug product	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8729057	2026-10-12		Drug product	2014-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8741881	2026-10-12	U-1103		2014-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8754070	2026-10-12		Drug product	2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8759329	2026-10-12		Drug product	2014-07-09	`31067a03dcf5…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1597076	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
0d84e5a6-11e9-4940-8991-21c611c4c32f	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
66993-951-88	Testosterone	88 g in 1 BOTTLE, PUMP	GEL	88		4
66993-951-88	Testosterone	1 in 1 CARTON	GEL	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-951-88	GM - Gram	66993-951	6266c9d5-92fd-49ba-aa62-60491b2ed85d	1	2025-06-13

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	Prasco Laboratories	0d84e5a6-11e9-4940-8991-21c611c4c32f	2024-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022309 application number: NDA022309 ndc (product): 66993-951

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	0d84e5a6-11e9-4940-8991-21c611c4c32f	4
1597126	testosterone 1.62 % (40.5MG / 2.5GM) Transdermal Gel	PSN	0d84e5a6-11e9-4940-8991-21c611c4c32f	4
1597126	2500 MG testosterone 0.0162 MG/MG Topical Gel	SCD	0d84e5a6-11e9-4940-8991-21c611c4c32f	4
1597076	60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel	SCD	0d84e5a6-11e9-4940-8991-21c611c4c32f	4
1597076	testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT	SY	0d84e5a6-11e9-4940-8991-21c611c4c32f	4
1597126	testosterone 1.62 % Transdermal Gel, 2.5 GM	SY	0d84e5a6-11e9-4940-8991-21c611c4c32f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
66993-951-88	66993095188	1 BOTTLE, PUMP in 1 CARTON (66993-951-88) / 88 g in 1 BOTTLE, PUMP	2025-05-19	No	No	Current