Androgel

Product NDC: 0051-8462
11-digit product format: 000518462
Labeler code: 0051
Product ID: 0051-8462_d34e7ee8-3f6b-4473-8e1b-f3a90467fb6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone
Dosage form: GEL
Route: TRANSDERMAL
Labeler: AbbVie Inc.
Application: NDA022309
Marketing category: NDA
Marketing start: 2011-04-29
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 16 mg/g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0051-8462		D	Discontinued by firm	2026-08-03
excluded package	package	0051-8462	0051-8462-30	D	Discontinued by firm	2026-08-03
excluded package	package	0051-8462	0051-8462-31	D	Discontinued by firm	2026-08-03
excluded package	package	0051-8462	0051-8462-33	D	Discontinued by firm	2026-08-03

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0051-8462-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0051-8462-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0051-8462-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0051-8462-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0051-8462-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0051-8462-33	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0051-8462-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0051-8462-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0051-8462-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0051-8462-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0051-8462-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0051-8462-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0051-8462-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0051-8462-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0051-8462-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0051-8462-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0051-8462-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0051-8462-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0051-8462-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0051-8462-31	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0051-8462-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0051-8462-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0051-8462-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0051-8462-31	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0051-8462-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0051-8462-31	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0051-8462-01	GM - Gram	0051-8462	bcffc0fb-dbc3-4ac3-9d18-ea28f1e84d0a	1	2015-07-20
0051-8462-12	GM - Gram	0051-8462	7bc2653a-b166-4fa9-b114-e50dac65080a	1	2015-07-20
0051-8462-30	GM - Gram	0051-8462	61aa5033-bcd4-4f54-9916-7cb144c2d3a6	1	2013-02-13
0051-8462-31	GM - Gram	0051-8462	7efc9065-8734-46b2-a66c-3e8d7cbfad08	1	2013-02-13
0051-8462-33	GM - Gram	0051-8462	d64c8784-bd5d-4d35-8e79-99bab638f335	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
testosterone	ACTIVE INGREDIENT	3XMK78S47O	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
testosterone	ACTIVE MOIETY	3XMK78S47O	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
alcohol	INACTIVE INGREDIENT	3K9958V90M	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
carbomer homopolymer type C	INACTIVE INGREDIENT	4Q93RCW27E	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79
water	INACTIVE INGREDIENT	059QF0KO0R	ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.]	79

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

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
0051-8462-30	00051846230	30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)	30 packet	2011-04-29	0000-00-00	No	No	Current
0051-8462-31	00051846231	30 PACKET in 1 CARTON (0051-8462-31) > 1.25 g in 1 PACKET (0051-8462-12)	30 packet	2011-04-29	0000-00-00	No	No	Current
0051-8462-33	00051846233	1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) > 88 g in 1 BOTTLE, PUMP		2011-04-29	0000-00-00	No	No	Current