Striant

Product NDC: 55056-3060
11-digit product format: 550563060
Labeler code: 55056
Product ID: 55056-3060_b6cd73a8-8abb-4be4-9174-7215c1096287
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: TABLET
Route: BUCCAL
Labeler: Columbia Laboratories, Inc.
Application: NDA021543
Marketing category: NDA
Marketing start: 2003-06-19
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 30 mg/1
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
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	55056-3060		I	Inactivated by FDA		2026-08-17
excluded package	package	55056-3060	55056-3060-1	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55056-3060-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55056-3060-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55056-3060-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55056-3060-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55056-3060-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55056-3060-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55056-3060-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55056-3060-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55056-3060-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55056-3060-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55056-3060-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55056-3060-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55056-3060-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55056-3060-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55056-3060-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55056-3060-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55056-3060-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55056-3060-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55056-3060-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55056-3060-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55056-3060-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55056-3060-1	`110d247fa046…`	`a55b01930146…`

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
N021543-001	STRIANT	TESTOSTERONE	30MG	TABLET, EXTENDED RELEASE / BUCCAL		RLD	2003-06-19

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD, RS	2003-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021543-001	6248358	2019-08-23	U-527	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021543-001	6248358	2019-08-23	U-527	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021543-001	6248358	2019-08-23	U-527	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021543-001	6248358	2019-08-23	U-527	`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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55056-3060-1	2019-10-21	C162847	48780-1	956f9ecf-c2a3-621f-e053-dbdaa90a74ad	STRIANT ® (testosterone buccal system) mucoadhesive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55056-3060-1	Striant	10 in 1 BLISTER PACK	TABLET	10		2
55056-3060-1	Striant	6 in 1 CARTON	TABLET	6		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55056-3060-1	EA - Each	55056-3060	58fde447-f115-4864-8c20-3724926f10b5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
testosterone	ACTIVE INGREDIENT	3XMK78S47O	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
testosterone	ACTIVE MOIETY	3XMK78S47O	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
carbomer 934	INACTIVE INGREDIENT	Z135WT9208	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
polycarbophil	INACTIVE INGREDIENT	W25LM17A4W	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55056-3060	STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20091214_ac47efbe-025b-4688-bcd3-a10a0b012b34.zip

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
858108	STRIANT 30 MG Buccal Film, Mucoadhesive	PSN	ac47efbe-025b-4688-bcd3-a10a0b012b34	2
858106	testosterone 30 MG Buccal Film, Mucoadhesive	PSN	ac47efbe-025b-4688-bcd3-a10a0b012b34	2
858108	testosterone 30 MG Buccal Film [Striant]	SBD	ac47efbe-025b-4688-bcd3-a10a0b012b34	2
858106	testosterone 30 MG Buccal Film	SCD	ac47efbe-025b-4688-bcd3-a10a0b012b34	2
858108	Striant 30 MG Buccal Film	SY	ac47efbe-025b-4688-bcd3-a10a0b012b34	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55056-3060-1	55056306001	10 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STRIANT ® (testosterone buccal system) mucoadhesive	Columbia Laboratories, Inc. \| Columbia Laboratories Inc	2009-11-19	HUMAN PRESCRIPTION DRUG LABEL	2