Temazepam

Product NDC: 65162-556
11-digit product format: 651620556
Labeler code: 65162
Product ID: 65162-556_20d2675f-af6d-480c-9152-6f722fb1ea22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA203482
Marketing category: ANDA
Marketing start: 2016-05-23
Substance: TEMAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	TE codes	Approval date
A203482-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23
A203482-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23
A203482-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23
A203482-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203482-001	AB
A203482-002	AB
A203482-003	AB
A203482-004	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 5 · 164 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	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	A203482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-004	AB	1	`011fe1cb6892…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-004	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A203482-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203482-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-004	AB	1	`4b0b4de00fa7…`

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
be68c6e0-17ad-40fe-9bc1-58abe24b53f6	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-556-03	Temazepam	30 in 1 BOTTLE	CAPSULE	30	23
65162-556-10	Temazepam	100 in 1 BOTTLE	CAPSULE	100	23
65162-556-11	Temazepam	1000 in 1 BOTTLE	CAPSULE	1000	23
65162-556-50	Temazepam	500 in 1 BOTTLE	CAPSULE	500	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-556-10	EA - Each	65162-556	7c7bc778-37b0-480f-a52c-cd11be956ecb	1	2016-09-02
65162-556-50	EA - Each	65162-556	b0067d77-87b2-4bde-8b1c-943b56a4310f	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-556	TEMAZEPAM CAPSULE [AMNEAL PHARMACEUTICALS LLC]	20	Current NDC, Legacy NDC, 4 package rows	20241031_be68c6e0-17ad-40fe-9bc1-58abe24b53f6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	066e25b2-8a1b-4b08-b585-ce36753bf104	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals LLC	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482 ndc (product): 65162-556
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals of New York LLC	6248295e-8176-48f8-8e9d-bba6deacaf0d	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482

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	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
485489	temazepam 22.5 MG Oral Capsule	PSN	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
198242	temazepam 30 MG Oral Capsule	PSN	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
198243	temazepam 7.5 MG Oral Capsule	PSN	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
198241	temazepam 15 MG Oral Capsule	SCD	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
485489	temazepam 22.5 MG Oral Capsule	SCD	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
198242	temazepam 30 MG Oral Capsule	SCD	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23
198243	temazepam 7.5 MG Oral Capsule	SCD	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-556-03	65162055603	30 CAPSULE in 1 BOTTLE (65162-556-03)	30 capsule	2016-05-23	0000-00-00	No	No	Current
65162-556-10	65162055610	100 CAPSULE in 1 BOTTLE (65162-556-10)	100 capsule	2016-05-23	0000-00-00	No	No	Current
65162-556-11	65162055611	1000 CAPSULE in 1 BOTTLE (65162-556-11)	1000 capsule	2016-05-23	0000-00-00	No	No	Current
65162-556-50	65162055650	500 CAPSULE in 1 BOTTLE (65162-556-50)	500 capsule	2016-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules, USP CIV Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	23
Temazepam Capsules, USP CIV Rx only	REMEDYREPACK INC.	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	4