testosterone

Product NDC: 63629-9310
11-digit product format: 636299310
Labeler code: 63629
Product ID: 63629-9310_6f355520-8406-4b95-9843-818049cf2948
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA204255
Marketing category: ANDA
Marketing start: 2017-06-28
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: 2026-12-31
Current FDA listing: Yes

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
A204255-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204255-001	AT

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`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	A204255-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204255-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204255-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204255-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204255-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204255-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204255-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204255-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204255-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204255-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204255-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204255-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204255-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204255-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204255-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204255-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204255-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204255-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204255-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204255-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204255-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204255-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204255-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204255-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204255-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204255-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204255-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204255-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204255-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204255-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204255-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204255-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204255-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204255-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204255-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204255-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204255-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204255-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204255-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204255-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: testosterone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE	30 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3XMK78S47O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1599949	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d22a072f-529b-4878-90fc-4365d9dc67e6	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-9310-1	testosterone	1 in 1 CARTON	SOLUTION	1		106
63629-9310-1	testosterone	110 mL in 1 BOTTLE, PUMP	SOLUTION	110		106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-9310-1	ML - Milliliter	63629-9310	55376e35-ceab-4706-add0-b39e6ddd78ee	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9310	TESTOSTERONE SOLUTION [BRYANT RANCH PREPACK]	106	Current NDC, Legacy NDC, 2 package rows	20240822_d22a072f-529b-4878-90fc-4365d9dc67e6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	c0c56607-e995-4bed-9c62-e33a722b38b5	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255
testosterone	TESTOSTERONE	Bryant Ranch Prepack	5be74193-de73-436d-a9a1-35a857bc8e0c	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255
testosterone	TESTOSTERONE	Bryant Ranch Prepack	d22a072f-529b-4878-90fc-4365d9dc67e6	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255 ndc (product): 63629-9310

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
1599949	testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT	PSN	d22a072f-529b-4878-90fc-4365d9dc67e6	106
1599949	60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution	SCD	d22a072f-529b-4878-90fc-4365d9dc67e6	106
1599949	60 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical Solution	SY	d22a072f-529b-4878-90fc-4365d9dc67e6	106
1599949	testosterone (as testosterone propionate) 2 % Topical Solution	SY	d22a072f-529b-4878-90fc-4365d9dc67e6	106
1599949	testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT	SY	d22a072f-529b-4878-90fc-4365d9dc67e6	106

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9310-1	63629931001	1 BOTTLE, PUMP in 1 CARTON (63629-9310-1) / 110 mL in 1 BOTTLE, PUMP	2022-07-06	0000-00-00	No	No	Current