Temazepam

Product NDC: 33261-101
11-digit product format: 332610101
Labeler code: 33261
Product ID: 33261-101_bbcc0af6-39fc-4c3c-8644-a773a0f0c611
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA070920
Marketing category: ANDA
Marketing start: 2017-12-18
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2019-12-31
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	33261-101		I	Inactivated by FDA		2026-08-07
excluded package	package	33261-101	33261-101-30	I	Inactivated by FDA		2026-08-07

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 · 42 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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`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	33261-101-30	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A070920-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10
A070920-002	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21
A070920-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12
A070920-004	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A070920-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070920-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070920-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070920-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070920-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070920-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070920-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-004	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3aa44f1-a660-94b4-7185-b48df8b066ff	Product name	5	20250522

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-101-30	2020-01-31	C162847	48780-1	9d75b9d0-8f65-f424-e053-dadaa90a57ce	Temazepam USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-101-30	Temazepam	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-101-30	EA - Each	33261-101	32563983-f4c1-48dd-9076-f54e8eb6bf09	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-101	TEMAZEPAM CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180817_c6053e97-1642-4da3-8dcb-f3858f5db963.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CHB1QD2QSS	TEMAZEPAM	846-50-4	TEMAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198241	temazepam 15 MG Oral Capsule	PSN	c6053e97-1642-4da3-8dcb-f3858f5db963	1
198241	temazepam 15 MG Oral Capsule	SCD	c6053e97-1642-4da3-8dcb-f3858f5db963	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-101-30	33261010130	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam USP	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-16	HUMAN PRESCRIPTION DRUG LABEL	1