Temazepam

Product NDC: 68788-8493
11-digit product format: 687888493
Labeler code: 68788
Product ID: 68788-8493_b38abef7-ba46-4b82-9712-9fe348e517d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211542
Marketing category: ANDA
Marketing start: 2023-07-24
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	Approval date
A211542-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23
A211542-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23
A211542-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23
A211542-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211542-001	AB
A211542-002	AB
A211542-003	AB
A211542-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`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	A211542-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211542-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211542-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-004	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198241	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
cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	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	Strength	SPL version
68788-8493-3	Temazepam	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8493-3	EA - Each	68788-8493	ecf2ffd5-02fb-430e-8ad4-fc94f8c13ddc	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8493	TEMAZEPAM CAPSULE [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 1 package rows	20240820_cbe5bd6a-f36a-4557-82d8-ef4e49d310e9.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	4a2ab77d-8b80-7eb1-e063-6394a90a1469	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542 ndc (product): 68788-8493
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	44461dcc-5c1e-4852-92d3-854ac0849e3d	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Golden State Medical Supply, Inc.	1ddc31b7-2b23-fb10-e063-6394a90a55f3	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	74a3db09-94d0-45e1-8c68-da7ca49d3d59	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Inc.	93b1be7f-ec41-46bb-a258-56cb459e2c92	2023-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Limited	db839409-8e95-41d3-804e-dcd5d11f4934	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542

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	cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	3
198241	temazepam 15 MG Oral Capsule	SCD	cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8493-3	68788849303	30 CAPSULE in 1 BOTTLE (68788-8493-3)	30 capsule	2023-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	3