Androderm

Product NDC: 0023-5990
11-digit product format: 000235990
Labeler code: 0023
Product ID: 0023-5990_899b8a9c-8153-4d71-8c8a-cbe407db732d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Allergan, Inc.
Application: NDA020489
Marketing category: NDA
Marketing start: 1995-09-29
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 2 mg/d
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0023-5990		D	Discontinued by firm		2026-08-03
excluded package	package	0023-5990	0023-5990-60	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 · 22 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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`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	0023-5990-60	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020489-001	ANDRODERM	TESTOSTERONE	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29
N020489-002	ANDRODERM	TESTOSTERONE	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02
N020489-003	ANDRODERM	TESTOSTERONE	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20
N020489-004	ANDRODERM	TESTOSTERONE	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020489-001	ANDRODERM	2.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1995-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020489-002	ANDRODERM	5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020489-003	ANDRODERM	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020489-004	ANDRODERM	4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2011-10-20	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-5990-60	EA - Each	0023-5990	1a2ffbd4-bb93-4657-af18-22ae155bb419	1	2018-12-13

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
0023-5990-60	00023599060	60 POUCH in 1 CARTON (0023-5990-60) > 1 PATCH in 1 POUCH > 1 d in 1 PATCH	60 pouch	1995-09-29	0000-00-00	No	No	Current