testosterone

Product NDC: 24979-130
Requested package NDC: 24979-130-26
11-digit product format: 249790130
Labeler code: 24979
Product ID: 24979-130_41a6f46f-ebc9-4eb2-ad09-a492afb0bae8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: SOLUTION
Route: TOPICAL
Labeler: TWi Pharmaceuticals, Inc.
Application: ANDA209836
Marketing category: ANDA
Marketing start: 2021-12-31
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 30 mg/1.5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24979-130	24979-130-26	D	Discontinued by firm		2026-09-14

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

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
A209836-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL			2021-09-03

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
2026-09-14 22:38:34	2026-08	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-09-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209836-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-09-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209836-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209836-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209836-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209836-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209836-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209836-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209836-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209836-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209836-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209836-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209836-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209836-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209836-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209836-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209836-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209836-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209836-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209836-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209836-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209836-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209836-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209836-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209836-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209836-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209836-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209836-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209836-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209836-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209836-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-130-26	ML - Milliliter	24979-130	abd4fb9a-fa29-4b53-8433-36431a81ad07	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-130	TESTOSTERONE SOLUTION [UPSHER-SMITH LABORATORIES, LLC]	5	Legacy NDC	20250312_0e943d17-3bf1-405a-9830-27653bfbf44b.zip

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
24979-130-26	24979013026	1 BOTTLE, PUMP in 1 CARTON (24979-130-26) > 110 mL in 1 BOTTLE, PUMP	2021-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
testosterone	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. Zhongli Plant Building II	2025-03-04	HUMAN PRESCRIPTION DRUG LABEL	5