Temazepam

Product NDC: 0378-5050
Requested package NDC: 0378-5050-77
11-digit product format: 003785050
Labeler code: 0378
Product ID: 0378-5050_57e251a0-cc54-4ae9-818d-a2f168e3fb13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA070920
Marketing category: ANDA
Marketing start: 1986-07-10
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 30 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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	0378-5050	0378-5050-77	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A070920-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10
A070920-002	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21
A070920-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12
A070920-004	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070920-001	TEMAZEPAM	30MG	CAPSULE / ORAL	1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	2010-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	2009-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070920-004	TEMAZEPAM	15MG	CAPSULE / ORAL	1986-07-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A070920-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070920-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070920-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070920-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070920-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070920-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070920-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070920-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070920-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070920-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070920-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070920-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070920-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070920-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070920-004	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3aa44f1-a660-94b4-7185-b48df8b066ff	Product name	5	20250522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5050-01	EA - Each	0378-5050	cc91df47-c37e-48e1-9050-2dfe482c49d7	1	2012-07-24
0378-5050-05	EA - Each	0378-5050	8b7a673d-c4db-453d-b6d7-675696907784	1	2012-07-24
0378-5050-77	EA - Each	0378-5050	3792a412-d398-42a5-9a46-4f49fcc55cdf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [MYLAN PHARMACEUTICALS INC.]	10
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.]	4
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [STAT RX USA LLC]	3
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [PROFICIENT RX LP]	1

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	30dadf97-4e8c-4630-b362-940313a8852e	4
198242	temazepam 30 MG Oral Capsule	PSN	30dadf97-4e8c-4630-b362-940313a8852e	4
198241	temazepam 15 MG Oral Capsule	SCD	30dadf97-4e8c-4630-b362-940313a8852e	4
198242	temazepam 30 MG Oral Capsule	SCD	30dadf97-4e8c-4630-b362-940313a8852e	4
198241	temazepam 15 MG Oral Capsule	PSN	55f28be9-7d69-467c-b5de-6e281ca9c498	3
198242	temazepam 30 MG Oral Capsule	PSN	55f28be9-7d69-467c-b5de-6e281ca9c498	3
198241	temazepam 15 MG Oral Capsule	SCD	55f28be9-7d69-467c-b5de-6e281ca9c498	3
198242	temazepam 30 MG Oral Capsule	SCD	55f28be9-7d69-467c-b5de-6e281ca9c498	3
198242	temazepam 30 MG Oral Capsule	PSN	baa39dac-c812-4feb-ad1b-436b29499eeb	1
198242	temazepam 30 MG Oral Capsule	SCD	baa39dac-c812-4feb-ad1b-436b29499eeb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5050-77	00378505077	90 CAPSULE in 1 BOTTLE, PLASTIC (0378-5050-77)	90 capsule	1986-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam - Proficient Rx LP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam - A-S Medication Solutions	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	6
Temazepam - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2019-09-25	HUMAN PRESCRIPTION DRUG LABEL	14
Temazepam, USP	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-16	HUMAN PRESCRIPTION DRUG LABEL	1
Temazepam - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-09-20	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-03-08	HUMAN PRESCRIPTION DRUG LABEL	3
Temazepam - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-09-04	HUMAN PRESCRIPTION DRUG LABEL	4