TEMAZEPAM

Product NDC: 71610-625
11-digit product format: 716100625
Labeler code: 71610
Product ID: 71610-625_1b2a670e-edfd-4ce9-e063-6294a90aaf23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA018163
Marketing category: NDA
Marketing start: 2010-02-23
Substance: TEMAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEMAZEPAM	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CHB1QD2QSS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198241	Internal RxNorm lookup
198242	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
a8deb28b-c5a3-4775-8bec-3f276698d064	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-625-10	TEMAZEPAM	10 in 1 BOTTLE	CAPSULE	10	4
71610-625-15	TEMAZEPAM	15 in 1 BOTTLE	CAPSULE	15	4
71610-625-20	TEMAZEPAM	20 in 1 BOTTLE	CAPSULE	20	4
71610-625-28	TEMAZEPAM	28 in 1 BOTTLE	CAPSULE	28	4
71610-625-30	TEMAZEPAM	30 in 1 BOTTLE	CAPSULE	30	4
71610-625-45	TEMAZEPAM	45 in 1 BOTTLE	CAPSULE	45	4
71610-625-53	TEMAZEPAM	60 in 1 BOTTLE	CAPSULE	60	4
71610-625-60	TEMAZEPAM	90 in 1 BOTTLE	CAPSULE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-625-10	EA - Each	71610-625	bc3bd8d4-46d2-4057-9e10-ecdfb45932da	1	2024-08-12
71610-625-15	EA - Each	71610-625	367a9da9-b66d-4271-ac94-ac4ac0c199d7	1	2022-03-09
71610-625-20	EA - Each	71610-625	4fea2df2-3549-412c-8a28-16c3ab2d0601	1	2024-08-12
71610-625-28	EA - Each	71610-625	db3e87e4-9742-4e7e-ba29-1fb428d6f516	1	2024-08-12
71610-625-30	EA - Each	71610-625	f5146203-38dd-4ead-a803-fbf661d8cc5b	1	2022-03-09
71610-625-45	EA - Each	71610-625	e3b0f6cc-a04d-4afe-9746-52836d73f5f9	1	2022-03-09
71610-625-53	EA - Each	71610-625	20aea86c-3cad-41f4-a426-d57ebb57c764	1	2022-03-09
71610-625-60	EA - Each	71610-625	dba1a9f6-e1b3-4eeb-aa3b-6599513e578f	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-625	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	4	Current NDC, Legacy NDC, 8 package rows	20240625_a8deb28b-c5a3-4775-8bec-3f276698d064.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 ndc (product): 71610-625
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
198241	temazepam 15 MG Oral Capsule	PSN	a8deb28b-c5a3-4775-8bec-3f276698d064	4
198242	temazepam 30 MG Oral Capsule	PSN	a8deb28b-c5a3-4775-8bec-3f276698d064	4
198241	temazepam 15 MG Oral Capsule	SCD	a8deb28b-c5a3-4775-8bec-3f276698d064	4
198242	temazepam 30 MG Oral Capsule	SCD	a8deb28b-c5a3-4775-8bec-3f276698d064	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-625-10	71610062510	10 CAPSULE in 1 BOTTLE (71610-625-10)	10 capsule	2024-06-14		No	No	Current
71610-625-15	71610062515	15 CAPSULE in 1 BOTTLE (71610-625-15)	15 capsule	2021-12-10	0000-00-00	No	No	Current
71610-625-20	71610062520	20 CAPSULE in 1 BOTTLE (71610-625-20)	20 capsule	2024-06-14		No	No	Current
71610-625-28	71610062528	28 CAPSULE in 1 BOTTLE (71610-625-28)	28 capsule	2024-06-14		No	No	Current
71610-625-30	71610062530	30 CAPSULE in 1 BOTTLE (71610-625-30)	30 capsule	2021-12-10	0000-00-00	No	No	Current
71610-625-45	71610062545	45 CAPSULE in 1 BOTTLE (71610-625-45)	45 capsule	2021-12-10	0000-00-00	No	No	Current
71610-625-53	71610062553	60 CAPSULE in 1 BOTTLE (71610-625-53)	60 capsule	2021-12-10	0000-00-00	No	No	Current
71610-625-60	71610062560	90 CAPSULE in 1 BOTTLE (71610-625-60)	90 capsule	2021-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules USP CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	4