TESTOSTERONE

Product NDC: 71589-013
11-digit product format: 715890013
Labeler code: 71589
Product ID: 71589-013_f37d0249-0de6-4657-bf15-fbf63ccd27b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TESTOSTERONE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Aleor Dermaceuticals Limited
Application: ANDA212882
Marketing category: ANDA
Marketing start: 2021-07-01
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 30 mg/1.5mL
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2022-12-31
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	71589-013		D	Discontinued by firm		2026-08-17
excluded package	package	71589-013	71589-013-11	D	Discontinued by firm		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 · 30 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	71589-013-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71589-013-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71589-013-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71589-013-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71589-013-11	D	Discontinued by firm	`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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	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	71589-013-11	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212882-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL			2021-06-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-06-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212882-001	AT	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71589-013-11	2025-03-10	C162847	48780-1	f386c64a-2c14-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TESTOSTERONE TOPICAL SOLUTION safely and effectively. See full prescribing information for TESTOSTERONE TOPICAL SOLUTION. TESTOSTERONE topical solution, for topical use CIII Initial U.S. Approval: 1953
71589-013-11	2023-01-30	C162847	48780-1	f386c64a-2c14-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TESTOSTERONE TOPICAL SOLUTION safely and effectively. See full prescribing information for TESTOSTERONE TOPICAL SOLUTION. TESTOSTERONE topical solution, for topical use CIII Initial U.S. Approval: 1953

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	Alembic Pharmaceuticals Inc.	e39289aa-681c-47ec-9461-52e7f17e5d71	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212882 application number: ANDA212882

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	Marketing start	Marketing end	Sample	Exclude flag	Status
71589-013-11	71589001311	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71589-013-11) > 110 mL in 1 BOTTLE, WITH APPLICATOR	2021-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TESTOSTERONE	Aleor Dermaceuticals Limited \| Contract Pharmaceuticals Limited Canada	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	2