Temazepam

Product NDC: 0904-6436
11-digit product format: 009046436
Labeler code: 0904
Product ID: 0904-6436_03705b1b-d68d-44b6-9ac4-5bacb01dacf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA071457
Marketing category: ANDA
Marketing start: 2015-03-25
Substance: TEMAZEPAM
Active strength: 7.5 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

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	0904-6436	0904-6436-60	D	Discontinued by firm		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 · 12 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…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A071457-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21
A071457-002	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22
A071457-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A071457-001	AB
A071457-002	AB
A071457-003	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 4 · 123 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	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A071457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071457-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071457-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEMAZEPAM	7.5 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
198243	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
2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	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	SPL version
0904-6436-04	Temazepam	30 in 1 CARTON	CAPSULE	30	9
0904-6436-04	Temazepam	1 in 1 BLISTER PACK	CAPSULE	1	9
0904-6436-60	Temazepam	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6436-04	EA - Each	0904-6436	84476fd3-0151-433f-a2b4-d036012e91e9	1	2015-04-03
0904-6436-60	EA - Each	0904-6436	9c3098f3-44c5-46f6-becd-9efdd579c7ef	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6436	TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 3 package rows	20250316_2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d.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 2 · 24 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): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	7e3fd8fe-fb8a-4577-b540-0e3fefe63627	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	4fe8192a-0f65-4958-8b6d-e87b9fae9eb5	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	bbb6e233-dc6b-43a7-8203-d91421d89921	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	A-S Medication Solutions	19b2711e-587a-47d2-ab62-d564e7b87195	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	62379cd5-a314-43eb-a1ee-33997623bfa3	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	dadc2f66-7fa5-4be4-a9d0-d96e5836f550	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Asclemed USA, Inc.	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
Temazepam	TEMAZEPAM	Major Pharmaceuticals	2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	2025-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457 ndc (product): 0904-6436
temazepam	TEMAZEPAM	AvPAK	08183adb-af12-fcb2-e063-6394a90afea4	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	ed068e02-a9c6-41ce-beca-83762720663d	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	8af67441-167f-4cc8-a498-c4377ba41c6d	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	5d83e474-0932-49ae-ad92-ca278cd5f1d5	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	NuCare Pharmaceuticals,Inc.	62fc08cd-8143-1652-e053-2a91aa0ad7ed	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	6559dfee-c29b-4707-8b30-8ca14bf23ea0	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9	2024-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
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): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1e37d59b-b8be-46ef-8706-fffd563a8c15	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1c08d30d-7c27-a09a-5240-7050771d5cc7	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	0e752dda-f00f-4123-b59f-aa911b897a5a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457

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
198243	temazepam 7.5 MG Oral Capsule	PSN	2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	9
198243	temazepam 7.5 MG Oral Capsule	SCD	2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	9
198243	temazepam 7.5 MG Oral Capsule	PSN	d4a241c7-a4de-4f6b-b831-e063cf8c3d54	2
198243	temazepam 7.5 MG Oral Capsule	SCD	d4a241c7-a4de-4f6b-b831-e063cf8c3d54	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6436-04	00904643604	30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK	30 blister pack	2015-03-25	0000-00-00	No	No	Current
0904-6436-60	00904643660	100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60)	100 capsule	2015-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam - Major Pharmaceuticals	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	9
Temazepam Capsules, USP Novel Laboratories, Inc. Rx only	Aphena Pharma Solutions - Tennessee, LLC	2017-06-16	HUMAN PRESCRIPTION DRUG LABEL	2