Temazepam

Product NDC: 53489-649
Requested package NDC: 53489-649-01
11-digit product format: 534890649
Labeler code: 53489
Product ID: 53489-649_4eeff7a1-a4af-41ac-98cf-2790d40c91df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA071175
Marketing category: ANDA
Marketing start: 2006-10-26
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 15 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	53489-649	53489-649-01	D	Discontinued by firm		2026-10-15

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 · 8 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071175-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL			1986-07-10
A071175-002	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL			2009-09-14

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 3 · 88 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
2026-10-15 13:18:30	2026-09	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2009-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2009-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2009-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071175-001	TEMAZEPAM	30MG	CAPSULE / ORAL		1986-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071175-002	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2009-09-14	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071175-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071175-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071175-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071175-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071175-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071175-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071175-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071175-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071175-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071175-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071175-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071175-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071175-002	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071175-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071175-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071175-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071175-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071175-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071175-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071175-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071175-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071175-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071175-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
Temazepam	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
D&C yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
FD&C blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
FD&C blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
FD&C red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
FD&C Yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CHB1QD2QSS	TEMAZEPAM	846-50-4	TEMAZEPAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-649-01	53489064901	100 CAPSULE in 1 BOTTLE, PLASTIC (53489-649-01)	100 capsule	2006-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEMAZEPAM CAPSULES USP CIV	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm, Inc.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	12