Testosterone

Product NDC: 45802-116
11-digit product format: 458020116
Labeler code: 45802
Product ID: 45802-116_becaacbf-6435-42f6-b034-71cb31b80b66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone
Dosage form: GEL
Route: TOPICAL
Labeler: Perrigo New York Inc
Application: NDA203098
Marketing category: NDA
Marketing start: 2014-12-27
Marketing end: 2020-03-01
Substance: TESTOSTERONE
Active strength: 13 mg/1.25g
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 0000-00-00
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	45802-116		D	Discontinued by firm	2026-10-05
excluded package	package	45802-116	45802-116-02	D	Discontinued by firm	2026-10-05
excluded package	package	45802-116	45802-116-39	D	Discontinued by firm	2026-10-05
excluded package	package	45802-116	45802-116-65	D	Discontinued by firm	2026-10-05

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 · 48 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	45802-116-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45802-116-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45802-116-39	`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	45802-116-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45802-116-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45802-116-39	`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	45802-116-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45802-116-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45802-116-39	`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	45802-116-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45802-116-65	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45802-116-39	`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	45802-116-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45802-116-65	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45802-116-39	`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	45802-116-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45802-116-65	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45802-116-39	`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	45802-116-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45802-116-65	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45802-116-39	`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	45802-116-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45802-116-65	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45802-116-39	`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	45802-116-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45802-116-65	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45802-116-39	`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	45802-116-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45802-116-65	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45802-116-39	`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	45802-116-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45802-116-65	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45802-116-39	`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	45802-116-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45802-116-65	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45802-116-39	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
N203098-001	TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31
N203098-002	TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31
N203098-003	TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-116-02	GM - Gram	45802-116	af564102-142a-4699-9d8d-be9a5aecce7f	1	2015-01-05
45802-116-39	GM - Gram	45802-116	052177fb-10c1-4d41-8e01-0e3261456ca0	1	2015-01-05
45802-116-65	GM - Gram	45802-116	c6309283-0d5f-4bbc-838e-c31084f7958c	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TESTOSTERONE	ACTIVE INGREDIENT	3XMK78S47O	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5
TESTOSTERONE	ACTIVE MOIETY	3XMK78S47O	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	TESTOSTERONE GEL [PERRIGO NEW YORK INC]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3XMK78S47O	TESTOSTERONE	58-22-0	TESTOSTERONE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Testosterone	Perrigo New York Inc	2019-09-04	HUMAN PRESCRIPTION DRUG LABEL	9
Testosterone	REMEDYREPACK INC.	2018-05-14	HUMAN PRESCRIPTION DRUG LABEL	1