temazepam

Product NDC: 67877-146
11-digit product format: 678770146
Labeler code: 67877
Product ID: 67877-146_45d37c04-846d-4f50-ac42-52b2d051d115
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories, LLC
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 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071456-001	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: temazepam
Listing expiration: 2027-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198241	Internal RxNorm lookup
198242	Internal RxNorm lookup
198243	Internal RxNorm lookup
485489	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
8f54731f-c5b7-492c-acb0-444c5fbb7029	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-146-01	temazepam	100 in 1 BOTTLE	CAPSULE	100		14
67877-146-05	temazepam	500 in 1 BOTTLE	CAPSULE	500		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-146-01	EA - Each	67877-146	bee88767-c5e5-4e29-a0a4-f342ee0c6b37	1	2012-07-24
67877-146-05	EA - Each	67877-146	0786546b-55ac-49e0-8551-fe842eb0b823	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3945
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
SHELLAC	INACTIVE INGREDIENT	46N107B71O	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	10
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]	2
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECTRX]	1
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECTRX]	1
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [DIRECTRX]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [DIRECTRX]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [DIRECTRX]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [DIRECTRX]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [DIRECTRX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [DIRECTRX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [DIRECTRX]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [DIRECTRX]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [DIRECTRX]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [DIRECTRX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [DIRECTRX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [DIRECTRX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [DIRECTRX]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-146	TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20231227_8f54731f-c5b7-492c-acb0-444c5fbb7029.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	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071456 application number: ANDA071456 ndc (product): 67877-146
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
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	a90d9165-da54-48e5-b144-ebeb6ff8d8ab	106
198241	temazepam 15 MG Oral Capsule	SCD	a90d9165-da54-48e5-b144-ebeb6ff8d8ab	106
198241	temazepam 15 MG Oral Capsule	PSN	ac08a51c-6c54-40da-9626-a4c82f337a3a	103
198241	temazepam 15 MG Oral Capsule	SCD	ac08a51c-6c54-40da-9626-a4c82f337a3a	103
198241	temazepam 15 MG Oral Capsule	PSN	5dc0c671-3cd8-4e75-9e76-19c1c17b30b2	102
198241	temazepam 15 MG Oral Capsule	SCD	5dc0c671-3cd8-4e75-9e76-19c1c17b30b2	102
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
198241	temazepam 15 MG Oral Capsule	PSN	a1f0ed55-9401-4afe-ba98-1ca115ba86b5	100
198241	temazepam 15 MG Oral Capsule	SCD	a1f0ed55-9401-4afe-ba98-1ca115ba86b5	100
198241	temazepam 15 MG Oral Capsule	PSN	19b2711e-587a-47d2-ab62-d564e7b87195	28
198242	temazepam 30 MG Oral Capsule	PSN	19b2711e-587a-47d2-ab62-d564e7b87195	28
198241	temazepam 15 MG Oral Capsule	SCD	19b2711e-587a-47d2-ab62-d564e7b87195	28
198242	temazepam 30 MG Oral Capsule	SCD	19b2711e-587a-47d2-ab62-d564e7b87195	28
198241	temazepam 15 MG Oral Capsule	PSN	45ef5e9c-f381-48d3-895d-e1d29be856ac	26
198241	temazepam 15 MG Oral Capsule	SCD	45ef5e9c-f381-48d3-895d-e1d29be856ac	26
198241	temazepam 15 MG Oral Capsule	PSN	a4231f67-6c04-4ce6-8c3d-6db52afaadbe	17
198241	temazepam 15 MG Oral Capsule	SCD	a4231f67-6c04-4ce6-8c3d-6db52afaadbe	17
198241	temazepam 15 MG Oral Capsule	PSN	65857a9b-a225-4887-b0dc-58ab6d60f9d0	16
198241	temazepam 15 MG Oral Capsule	SCD	65857a9b-a225-4887-b0dc-58ab6d60f9d0	16
198241	temazepam 15 MG Oral Capsule	PSN	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
485489	temazepam 22.5 MG Oral Capsule	PSN	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198242	temazepam 30 MG Oral Capsule	PSN	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198243	temazepam 7.5 MG Oral Capsule	PSN	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198241	temazepam 15 MG Oral Capsule	SCD	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
485489	temazepam 22.5 MG Oral Capsule	SCD	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198242	temazepam 30 MG Oral Capsule	SCD	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198243	temazepam 7.5 MG Oral Capsule	SCD	8f54731f-c5b7-492c-acb0-444c5fbb7029	14
198241	temazepam 15 MG Oral Capsule	PSN	d83e14ae-9823-e57b-e053-2a95a90a8524	5
198241	temazepam 15 MG Oral Capsule	SCD	d83e14ae-9823-e57b-e053-2a95a90a8524	5
198241	temazepam 15 MG Oral Capsule	PSN	b2422ca0-2f06-419f-aa0e-88c556b62399	4
198241	temazepam 15 MG Oral Capsule	PSN	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	4
198241	temazepam 15 MG Oral Capsule	PSN	904b8986-24da-48eb-bb0a-33d41b4eb005	4
198241	temazepam 15 MG Oral Capsule	PSN	d18cb775-d96f-1172-e053-2995a90a1333	4
198242	temazepam 30 MG Oral Capsule	PSN	b2422ca0-2f06-419f-aa0e-88c556b62399	4
198242	temazepam 30 MG Oral Capsule	PSN	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	4
198241	temazepam 15 MG Oral Capsule	SCD	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	4
198241	temazepam 15 MG Oral Capsule	SCD	d18cb775-d96f-1172-e053-2995a90a1333	4
198241	temazepam 15 MG Oral Capsule	SCD	b2422ca0-2f06-419f-aa0e-88c556b62399	4
198241	temazepam 15 MG Oral Capsule	SCD	904b8986-24da-48eb-bb0a-33d41b4eb005	4
198242	temazepam 30 MG Oral Capsule	SCD	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	4
198242	temazepam 30 MG Oral Capsule	SCD	b2422ca0-2f06-419f-aa0e-88c556b62399	4
198241	temazepam 15 MG Oral Capsule	PSN	806e0bc3-6e6d-4750-aaec-a968baa244f4	3
198241	temazepam 15 MG Oral Capsule	PSN	7b74c9aa-cb40-4a45-abab-845ad2fa28cf	3
198241	temazepam 15 MG Oral Capsule	PSN	08183adb-af12-fcb2-e063-6394a90afea4	3
198241	temazepam 15 MG Oral Capsule	PSN	42b81d6f-8171-4cd0-ab79-f031a8254d65	3
198242	temazepam 30 MG Oral Capsule	PSN	08183adb-af12-fcb2-e063-6394a90afea4	3
198241	temazepam 15 MG Oral Capsule	SCD	7b74c9aa-cb40-4a45-abab-845ad2fa28cf	3
198241	temazepam 15 MG Oral Capsule	SCD	08183adb-af12-fcb2-e063-6394a90afea4	3
198241	temazepam 15 MG Oral Capsule	SCD	42b81d6f-8171-4cd0-ab79-f031a8254d65	3
198241	temazepam 15 MG Oral Capsule	SCD	806e0bc3-6e6d-4750-aaec-a968baa244f4	3
198242	temazepam 30 MG Oral Capsule	SCD	08183adb-af12-fcb2-e063-6394a90afea4	3
198241	temazepam 15 MG Oral Capsule	PSN	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198241	temazepam 15 MG Oral Capsule	PSN	ccf04879-3ad5-4fc3-89f5-879c97887017	2
485489	temazepam 22.5 MG Oral Capsule	PSN	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198242	temazepam 30 MG Oral Capsule	PSN	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198242	temazepam 30 MG Oral Capsule	PSN	ccf04879-3ad5-4fc3-89f5-879c97887017	2
198243	temazepam 7.5 MG Oral Capsule	PSN	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198241	temazepam 15 MG Oral Capsule	SCD	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198241	temazepam 15 MG Oral Capsule	SCD	ccf04879-3ad5-4fc3-89f5-879c97887017	2
485489	temazepam 22.5 MG Oral Capsule	SCD	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198242	temazepam 30 MG Oral Capsule	SCD	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198242	temazepam 30 MG Oral Capsule	SCD	ccf04879-3ad5-4fc3-89f5-879c97887017	2
198243	temazepam 7.5 MG Oral Capsule	SCD	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2
198241	temazepam 15 MG Oral Capsule	PSN	6979644e-0587-4040-b754-5dce5eda87a4	1
198241	temazepam 15 MG Oral Capsule	PSN	f7c31cab-c96b-45e1-8c29-48e17b3fd731	1
198241	temazepam 15 MG Oral Capsule	SCD	6979644e-0587-4040-b754-5dce5eda87a4	1
198241	temazepam 15 MG Oral Capsule	SCD	f7c31cab-c96b-45e1-8c29-48e17b3fd731	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-146-01	67877014601	100 CAPSULE in 1 BOTTLE (67877-146-01)	100 capsule	1987-04-21	0000-00-00	No	No	Current
67877-146-05	67877014605	500 CAPSULE in 1 BOTTLE (67877-146-05)	500 capsule	1987-04-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
temazepam - Ascend Laboratories, LLC \| Novel Laboratories, Inc.	Ascend Laboratories, LLC \| Novel Laboratories, Inc.	2026-08-05	Human Prescription Drug Label	23
temazepam - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	17
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	100
temazepam - A-S Medication Solutions	A-S Medication Solutions	2025-10-27	Human Prescription Drug Label	28
temazepam - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	26
temazepam - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	2
temazepam - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	3
TEMAZEPAM Capsules, USP CIV Rx Only	AvPAK	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
temazepam - Quality Care Products LLC	Quality Care Products LLC	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	3955
temazepam - ATLANTIC BIOLOGICALS CORP.	ATLANTIC BIOLOGICALS CORP.	2024-06-04	Human Prescription Drug Label	3
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	106
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	103
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	101
temazepam - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2024-01-23	Human Prescription Drug Label	4
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-11-03	HUMAN PRESCRIPTION DRUG LABEL	102
Temazepam - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
temazepam - Proficient Rx LP	Proficient Rx LP	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	4
temazepam - Bryant Ranch Prepack	Bryant Ranch Prepack	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	21