temazepam

Product NDC: 72162-1824
11-digit product format: 721621824
Labeler code: 72162
Product ID: 72162-1824_6c8efa4c-2cd1-47c0-8e82-cfdd16a7455b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071456
Marketing category: ANDA
Marketing start: 1987-04-21
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071456-001	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB		1987-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071456-001	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 2 · 41 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	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071456-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071456-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071456-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071456-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071456-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071456-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071456-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071456-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071456-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071456-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071456-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071456-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071456-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071456-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071456-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071456-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071456-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071456-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071456-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071456-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071456-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071456-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071456-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071456-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071456-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071456-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071456-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071456-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071456-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071456-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071456-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071456-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071456-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071456-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071456-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071456-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071456-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071456-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071456-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071456-001	AB	1	`cb3db0bc1861…`

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
432252c6-648f-4c53-976c-ee271ba435bd	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-1824-1	temazepam	100 in 1 BOTTLE	CAPSULE	100		101
72162-1824-5	temazepam	500 in 1 BOTTLE	CAPSULE	500		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1824-1	EA - Each	72162-1824	facf4de6-d141-49be-9554-a336f4b5a057	1	2024-04-05
72162-1824-5	EA - Each	72162-1824	42deadbb-da03-4060-8119-27adc05898aa	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1824	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	101	Current NDC, 2 package rows	20240308_432252c6-648f-4c53-976c-ee271ba435bd.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
temazepam	TEMAZEPAM	Ascend Laboratories, LLC	8f54731f-c5b7-492c-acb0-444c5fbb7029	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	REMEDYREPACK INC.	65857a9b-a225-4887-b0dc-58ab6d60f9d0	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Bryant Ranch Prepack	a1f0ed55-9401-4afe-ba98-1ca115ba86b5	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	A-S Medication Solutions	19b2711e-587a-47d2-ab62-d564e7b87195	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	45ef5e9c-f381-48d3-895d-e1d29be856ac	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Asclemed USA, Inc.	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	42b81d6f-8171-4cd0-ab79-f031a8254d65	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	AvPAK	08183adb-af12-fcb2-e063-6394a90afea4	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
Temazepam	TEMAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	d83e14ae-9823-e57b-e053-2a95a90a8524	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
Temazepam	TEMAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	f885bb1a-0445-c452-e053-6394a90ae8aa	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Bryant Ranch Prepack	a90d9165-da54-48e5-b144-ebeb6ff8d8ab	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Bryant Ranch Prepack	ac08a51c-6c54-40da-9626-a4c82f337a3a	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Bryant Ranch Prepack	432252c6-648f-4c53-976c-ee271ba435bd	2024-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456 ndc (product): 72162-1824
temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b2422ca0-2f06-419f-aa0e-88c556b62399	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Bryant Ranch Prepack	5dc0c671-3cd8-4e75-9e76-19c1c17b30b2	2023-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Proficient Rx LP	904b8986-24da-48eb-bb0a-33d41b4eb005	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456
temazepam	TEMAZEPAM	Proficient Rx LP	ccf04879-3ad5-4fc3-89f5-879c97887017	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456

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	432252c6-648f-4c53-976c-ee271ba435bd	101
198241	temazepam 15 MG Oral Capsule	SCD	432252c6-648f-4c53-976c-ee271ba435bd	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1824-1	72162182401	100 CAPSULE in 1 BOTTLE (72162-1824-1)	100 capsule	2024-03-07	No	No	Current
72162-1824-5	72162182405	500 CAPSULE in 1 BOTTLE (72162-1824-5)	500 capsule	2024-03-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	101