Temazepam

Product NDC: 0228-2076
11-digit product format: 002282076
Labeler code: 0228
Product ID: 0228-2076_3050ee1e-c494-48ce-be40-6424e9661d87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA071620
Marketing category: ANDA
Marketing start: 1990-09-30
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

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 Identifiers#

Field, Values table
Field	Values
Unii	CHB1QD2QSS
Rxcui	198241, 198242

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3aa44f1-a660-94b4-7185-b48df8b066ff	Product name	5	20250522
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0228-2076-10	Temazepam	100 in 1 BOTTLE	CAPSULE	100		25
0228-2076-50	Temazepam	500 in 1 BOTTLE	CAPSULE	500		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2076-10	EA - Each	0228-2076	d508b0a1-2b3f-4e79-b97e-4eacb13ae0c5	1	2013-02-13
0228-2076-50	EA - Each	0228-2076	8b0f6293-fbfa-44a0-80d1-40299692163f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]	5
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [RXCHANGE CO.]	2
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECT RX]	1
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECT RX]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [DIRECT RX]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [DIRECT RX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2076	TEMAZEPAM CAPSULE [ACTAVIS PHARMA, INC.]	24	Current NDC, Legacy NDC, 2 package rows	20250213_a4370eb4-b00d-4247-af8d-980e59fbbec6.zip

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	a4370eb4-b00d-4247-af8d-980e59fbbec6	25
198242	temazepam 30 MG Oral Capsule	PSN	a4370eb4-b00d-4247-af8d-980e59fbbec6	25
198241	temazepam 15 MG Oral Capsule	SCD	a4370eb4-b00d-4247-af8d-980e59fbbec6	25
198242	temazepam 30 MG Oral Capsule	SCD	a4370eb4-b00d-4247-af8d-980e59fbbec6	25
198241	temazepam 15 MG Oral Capsule	PSN	dbd39517-62f5-44b0-844f-e1cbf3c6ca2e	13
198241	temazepam 15 MG Oral Capsule	PSN	38afa73c-7c87-440d-bece-f268e8e4a44c	13
198241	temazepam 15 MG Oral Capsule	PSN	85919240-0bac-4ed9-97aa-f1aa29be7ffa	13
198241	temazepam 15 MG Oral Capsule	SCD	dbd39517-62f5-44b0-844f-e1cbf3c6ca2e	13
198241	temazepam 15 MG Oral Capsule	SCD	38afa73c-7c87-440d-bece-f268e8e4a44c	13
198241	temazepam 15 MG Oral Capsule	SCD	85919240-0bac-4ed9-97aa-f1aa29be7ffa	13
198241	temazepam 15 MG Oral Capsule	PSN	74f261c5-a960-44ef-be4c-4dcefd881c3f	3
198241	temazepam 15 MG Oral Capsule	SCD	74f261c5-a960-44ef-be4c-4dcefd881c3f	3
198241	temazepam 15 MG Oral Capsule	PSN	2461dfbd-5704-42f4-bde7-d1461811d898	2
198241	temazepam 15 MG Oral Capsule	PSN	c270129a-03e8-4c3d-a47e-0e533f05b2ad	2
198242	temazepam 30 MG Oral Capsule	PSN	2461dfbd-5704-42f4-bde7-d1461811d898	2
198241	temazepam 15 MG Oral Capsule	SCD	c270129a-03e8-4c3d-a47e-0e533f05b2ad	2
198241	temazepam 15 MG Oral Capsule	SCD	2461dfbd-5704-42f4-bde7-d1461811d898	2
198242	temazepam 30 MG Oral Capsule	SCD	2461dfbd-5704-42f4-bde7-d1461811d898	2
198241	temazepam 15 MG Oral Capsule	PSN	f0f4184e-e7e1-49e6-9b93-ac599ac524c6	1
198241	temazepam 15 MG Oral Capsule	SCD	f0f4184e-e7e1-49e6-9b93-ac599ac524c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2076-10	00228207610	100 CAPSULE in 1 BOTTLE (0228-2076-10)	100 capsule	1990-09-30	0000-00-00	No	No	Current
0228-2076-50	00228207650	500 CAPSULE in 1 BOTTLE (0228-2076-50)	500 capsule	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules, USP CIV Rx only	REMEDYREPACK INC.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	13
Temazepam Capsules, USP CIV Rx only	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	13
Temazepam Capsules, USP CIV Rx only	Actavis Pharma, Inc.	2025-01-01	HUMAN PRESCRIPTION DRUG LABEL	25
TEMAZEPAM	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam Capsules, USP CIV Rx only	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	13
TEMAZEPAM CAPSULES, USP 40-8787 Revised - January 2009 Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-05-17	HUMAN PRESCRIPTION DRUG LABEL	2
TEMAZEPAM CAPSULES, USP CIV 40-9177 Revised – June 2012 Rx only	RxChange Co.	2014-12-01	HUMAN PRESCRIPTION DRUG LABEL	2
TEMAZEPAM CAPSULES, USP CIV	STAT Rx USA LLC \| PSS World Medical Inc.	2012-08-20	HUMAN PRESCRIPTION DRUG LABEL	1

Temazepam

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#