Testosterone

Product NDC: 70518-1171
11-digit product format: 705181171
Labeler code: 70518
Product ID: 70518-1171_6c2bdcb4-6f4b-bebd-e053-2a91aa0ad09c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Testosterone
Dosage form: GEL
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: NDA203098
Marketing category: NDA
Marketing start: 2018-05-14
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 13 mg/1.25g
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	70518-1171		D	Discontinued by firm		2026-10-05
excluded package	package	70518-1171	70518-1171-0	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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1171-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1171-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1171-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1171-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1171-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1171-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1171-0	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1171-0	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1171-0	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1171-0	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1171-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1171-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70518-1171-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70518-1171-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70518-1171-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70518-1171-0	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70518-1171-0	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70518-1171-0	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70518-1171-0	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70518-1171-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	70518-1171-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1171-0	2025-11-11	C162847	48780-1	9d75b9d0-50c2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953
70518-1171-0	2020-01-31	C162847	48780-1	9d75b9d0-50c2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1171	TESTOSTERONE GEL [REMEDYREPACK INC.]	1	Legacy NDC	20180514_fa29b98e-28a7-41f5-8fc7-718ea092de27.zip