TEMAZEPAM

Product NDC: 61919-263
11-digit product format: 619190263
Labeler code: 61919
Product ID: 61919-263_7bc99758-11bc-4b1d-96a4-a30926d9dfd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TEMAZEPAM
Dosage form: CAPSULE
Route: ORAL
Labeler: DirectRX
Application: ANDA071456
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-263		I	Inactivated by FDA		2026-08-07
excluded package	package	61919-263	61919-263-30	I	Inactivated by FDA		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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-263-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-263-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-263-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-263-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-263-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-263-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-263-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-263-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-263-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-263-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-263-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-263-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-263-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-263-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-263-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-263-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-263-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-263-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-263-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-263-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-263-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-263-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071456-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-04-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071456-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-263-30	2020-01-31	C162847	48780-1	9d75b9cf-f617-f424-e053-dadaa90a57ce	TEMAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-263-30	TEMAZEPAM	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-263-30	EA - Each	61919-263	051b866f-2781-4af4-aeae-286ecdf3e2f4	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
temazepam	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECTRX]	1
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [DIRECTRX]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMAZEPAM CAPSULE [DIRECTRX]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMAZEPAM CAPSULE [DIRECTRX]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMAZEPAM CAPSULE [DIRECTRX]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMAZEPAM CAPSULE [DIRECTRX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TEMAZEPAM CAPSULE [DIRECTRX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEMAZEPAM CAPSULE [DIRECTRX]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TEMAZEPAM CAPSULE [DIRECTRX]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [DIRECTRX]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMAZEPAM CAPSULE [DIRECTRX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [DIRECTRX]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMAZEPAM CAPSULE [DIRECTRX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMAZEPAM CAPSULE [DIRECTRX]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMAZEPAM CAPSULE [DIRECTRX]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [DIRECTRX]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [DIRECTRX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-263	TEMAZEPAM CAPSULE [DIRECTRX]	1	Legacy NDC, 1 package rows	20151027_f7c31cab-c96b-45e1-8c29-48e17b3fd731.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
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	f7c31cab-c96b-45e1-8c29-48e17b3fd731	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	Status
61919-263-30	61919026330	30 in 1 BOTTLE	Historical