Testosterone

Product NDC: 66993-955
11-digit product format: 669930955
Labeler code: 66993
Product ID: 66993-955_c9fee58e-0843-4cf3-8d60-c578dc9a288f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL
Route: TRANSDERMAL
Labeler: Prasco Laboratories
Application: NDA021015
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-05-19
Substance: TESTOSTERONE
Active strength: 50 mg/5g
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
N021015-001	ANDROGEL	TESTOSTERONE	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28
N021015-002	ANDROGEL	TESTOSTERONE	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28
N021015-003	ANDROGEL	TESTOSTERONE	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021015-001	AB1
N021015-002	AB1
N021015-003	AB1

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	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 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	N021015-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021015-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-003	AB1	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-003	AB1	1	`d8e5a09893c0…`
2019-12-13 00:20 UTC	2019-12	N021015-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021015-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021015-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-002	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021015-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021015-002	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021015-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021015-002	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021015-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021015-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021015-003	AB	1	`3f01610625f2…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021015-001	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`5aa47cf7b7d7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE	50 mg/5g

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
1596780	Internal RxNorm lookup
1597123	Internal RxNorm lookup
1597129	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
68b2375d-0365-4797-bc3d-63531c9f42fd	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
66993-955-30	Testosterone	5 g in 1 PACKET	GEL	5		3
66993-955-30	Testosterone	30 in 1 CARTON	GEL	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-955-30	GM - Gram	66993-955	44b8f9c0-0af0-4f28-a9de-ba7b8a7dee82	1	2025-12-16

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	68b2375d-0365-4797-bc3d-63531c9f42fd	2024-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021015 application number: NDA021015 ndc (product): 66993-955

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
1596780	testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT	PSN	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597123	testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel	PSN	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597129	testosterone 1 % (50 MG / 5 GM) Transdermal Gel	PSN	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597123	2500 MG testosterone 0.01 MG/MG Topical Gel	SCD	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597129	5000 MG testosterone 0.01 MG/MG Topical Gel	SCD	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1596780	60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel	SCD	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597123	testosterone 1 % Transdermal Gel, 2.5 GM	SY	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1596780	testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT	SY	68b2375d-0365-4797-bc3d-63531c9f42fd	3
1597129	testosterone 50 MG Transdermal Gel, 5 GM	SY	68b2375d-0365-4797-bc3d-63531c9f42fd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66993-955-30	66993095530	30 PACKET in 1 CARTON (66993-955-30) / 5 g in 1 PACKET	30 packet	2025-12-01	No	No	Current