Androgel

Product NDC: 21695-112
11-digit product format: 216950112
Labeler code: 21695
Product ID: 21695-112_77215d87-ad22-4169-bd5f-a453f10b21ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL
Route: TRANSDERMAL
Labeler: Rebel Distributors Corp.
Application: NDA021015
Marketing category: NDA
Marketing start: 2003-06-05
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 10 mg/g
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-112		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-112	21695-112-30	I	Inactivated by FDA		2026-08-17

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 · 44 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	21695-112-30	`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	21695-112-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-112-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-112-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-112-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-112-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-112-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-112-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-112-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-112-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-112-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-112-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-112-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-112-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-112-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-112-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-112-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-112-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-112-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-112-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-112-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-112-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 06:07:40	2026-07	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	AB1	RLD	2003-09-26	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021015-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-003	AB1	1	`caaa826d4ba7…`
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…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-112-30	2019-09-24	C162847	48780-1	934fe258-4b2d-48b1-e053-8cdaa90a720a	Androgel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-112-30	Androgel	30 in 1 CARTON	GEL	30		1
21695-112-30	Androgel	5 g in 1 PACKET	GEL	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-112-30	GM - Gram	21695-112	3c359deb-e9c0-4520-9eeb-299df3c9bded	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 [REBEL DISTRIBUTORS CORP.]	1
TESTOSTERONE	ACTIVE MOIETY	3XMK78S47O	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-112	ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 2 package rows	20110314_77215d87-ad22-4169-bd5f-a453f10b21ef.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	Prasco Laboratories	68b2375d-0365-4797-bc3d-63531c9f42fd	2024-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021015 application number: NDA021015

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
1597130	AndroGel 1 % (50MG / 5GM) Transdermal Gel	PSN	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597129	testosterone 1 % (50 MG / 5 GM) Transdermal Gel	PSN	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597130	5000 MG testosterone 0.01 MG/MG Topical Gel [Androgel]	SBD	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597129	5000 MG testosterone 0.01 MG/MG Topical Gel	SCD	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597130	5000 MG Androgel 0.01 MG/MG Topical Gel	SY	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597130	Androgel 1 % Transdermal Gel, 5 GM	SY	77215d87-ad22-4169-bd5f-a453f10b21ef	1
1597129	testosterone 50 MG Transdermal Gel, 5 GM	SY	77215d87-ad22-4169-bd5f-a453f10b21ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-112-30	21695011230	30 in 1 CARTON	Historical