TEMAZEPAM

Product NDC: 50090-3563
Requested package NDC: 50090-3563-0
11-digit product format: 500903563
Labeler code: 50090
Product ID: 50090-3563_64ba3b21-db71-4037-97b9-24f8ecf3d65b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA018163
Marketing category: NDA
Marketing start: 2010-02-23
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 23 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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	50090-3563	50090-3563-0	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	RLD / RS	Approval date
N018163-001	RESTORIL	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N018163-002	RESTORIL	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N018163-003	RESTORIL	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25
N018163-004	RESTORIL	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N018163-001	AB
N018163-002	AB
N018163-003	AB
N018163-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018163-001	RESTORIL	15MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-002	RESTORIL	30MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-003	RESTORIL	7.5MG	CAPSULE / ORAL	AB	RLD	1991-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-004	RESTORIL	22.5MG	CAPSULE / ORAL	AB	RLD	2004-11-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018163-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018163-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018163-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018163-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018163-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018163-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018163-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018163-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018163-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018163-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018163-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018163-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018163-004	AB	1	`d06236e962d9…`

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
50090-3563-0	2023-01-30	C162847	48780-1	f386c64a-11c2-0266-e053-dadaa90a7c1a	Temazepam Capsules USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3563-0	TEMAZEPAM	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3563	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 1 package rows	20200121_dbea1ee6-cdaa-4b1a-8dd5-4bff31b2a1ef.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RESTORIL	TEMAZEPAM	SpecGx LLC	bc56f7fd-1aaf-48ff-8aa7-d467e59e1015	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163
TEMAZEPAM	TEMAZEPAM	SpecGx LLC	c9bc61b4-a579-4003-98da-b6f6e381c150	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163
Temazepam	TEMAZEPAM	American Health Packaging	a3f06243-fa03-4cbd-951a-144ec43dcdfd	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163
TEMAZEPAM	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	97afda58-4daf-4192-bd87-3ccbb000ee52	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163
TEMAZEPAM	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a8deb28b-c5a3-4775-8bec-3f276698d064	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163
TEMAZEPAM	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1	2019-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018163 application number: NDA018163

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
485489	temazepam 22.5 MG Oral Capsule	PSN	dbea1ee6-cdaa-4b1a-8dd5-4bff31b2a1ef	3
485489	temazepam 22.5 MG Oral Capsule	SCD	dbea1ee6-cdaa-4b1a-8dd5-4bff31b2a1ef	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3563-0	50090356300	30 CAPSULE in 1 BOTTLE (50090-3563-0)	30 capsule	2018-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules USP CIV Rx only	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3