testosterone

Product NDC: 16714-967
11-digit product format: 167140967
Labeler code: 16714
Product ID: 16714-967_4a345c32-af7e-4998-a0a9-e8f3adef95ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL
Route: TOPICAL
Labeler: Northstar Rx LLC
Application: ANDA204268
Marketing category: ANDA
Marketing start: 2019-11-06
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 20 mg/1.25g
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	16714-967		D	Discontinued by firm		2026-08-17
excluded package	package	16714-967	16714-967-01	D	Discontinued by firm		2026-08-17

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
A204268-001	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB		2015-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204268-001	AB

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 2 · 42 observed 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	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204268-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204268-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204268-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204268-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204268-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204268-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204268-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204268-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204268-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204268-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204268-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204268-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204268-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204268-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204268-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204268-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204268-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204268-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204268-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204268-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204268-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204268-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204268-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204268-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204268-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204268-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204268-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204268-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204268-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204268-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204268-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204268-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204268-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204268-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204268-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204268-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204268-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204268-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204268-001	PC	2019-04-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204268-001	PC	2019-04-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	PC	2019-04-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	PC	2019-04-10	`ea99ee380514…`

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
16714-967-01	GM - Gram	16714-967	a4cd7124-96d2-4f18-8ee3-35a38463b55c	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-967	TESTOSTERONE GEL [NORTHSTAR RX LLC]	8	Legacy NDC	20240315_2d55b825-8eab-4091-bdf2-9c52d111b8eb.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	54fcdcb9-fb0e-4164-9e51-f2a5feae3217	2025-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268
testosterone	TESTOSTERONE	Bryant Ranch Prepack	9e10a37a-9c40-456b-a362-2fa8eae31e84	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268
testosterone	TESTOSTERONE	Bryant Ranch Prepack	78384754-5883-46b1-84e7-c063b4b4be82	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268
testosterone	TESTOSTERONE	Bryant Ranch Prepack	86254445-efd1-46d9-8236-3a0d98316f28	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1597120	testosterone 1.62 % (20.25MG / 1.25GM) Transdermal Gel	PSN	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10
1597126	testosterone 1.62 % (40.5MG / 2.5GM) Transdermal Gel	PSN	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10
1597120	1250 MG testosterone 0.0162 MG/MG Topical Gel	SCD	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10
1597126	2500 MG testosterone 0.0162 MG/MG Topical Gel	SCD	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10
1597120	testosterone 1.62 % Transdermal Gel, 1.25 GM	SY	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10
1597126	testosterone 1.62 % Transdermal Gel, 2.5 GM	SY	2d55b825-8eab-4091-bdf2-9c52d111b8eb	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-967-01	16714096701	1 BOTTLE, PUMP in 1 CARTON (16714-967-01) > 88 g in 1 BOTTLE, PUMP	2019-11-06	0000-00-00	No	No	Current