temazepam

Product NDC: 52959-535
11-digit product format: 529590535
Labeler code: 52959
Product ID: 52959-535_54f020bf-54a5-4a05-98f2-c7ca8e25be3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA071456
Marketing category: ANDA
Marketing start: 1987-04-21
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-535		I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-10	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-12	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-15	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-20	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-24	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-28	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-30	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-40	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-535	52959-535-60	I	Inactivated by FDA	2026-08-10

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 4 · 220 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-535-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-535-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-535-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-535-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-535-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-535-40	`cdf11ea48f46…`	`ba0047e9e063…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-535-10	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-12	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-15	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-20	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-24	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-28	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-30	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-40	2ed81194-be24-45a0-8dde-fbc6ad3d7abe
52959-535-60	2ed81194-be24-45a0-8dde-fbc6ad3d7abe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-535-30	Strazepam	30 in 1 BOTTLE	CAPSULE	30	15 mg	17
52959-535-10	temazepam	10 in 1 BOTTLE	CAPSULE	10		4
52959-535-12	temazepam	121 in 1 BOTTLE	CAPSULE	121		4
52959-535-15	temazepam	15 in 1 BOTTLE	CAPSULE	15		4
52959-535-20	temazepam	20 in 1 BOTTLE	CAPSULE	20		4
52959-535-24	temazepam	24 in 1 BOTTLE	CAPSULE	24		4
52959-535-28	temazepam	28 in 1 BOTTLE	CAPSULE	28		4
52959-535-30	temazepam	30 in 1 BOTTLE	CAPSULE	30		4
52959-535-40	temazepam	40 in 1 BOTTLE	CAPSULE	40		4
52959-535-60	temazepam	60 in 1 BOTTLE	CAPSULE	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-535-10	EA - Each	52959-535	c3fcd137-a521-4794-8639-922a737ee9cd	1	2012-07-24
52959-535-12	EA - Each	52959-535	23a4fdab-ee15-4e12-b07d-177358251a29	1	2012-07-24
52959-535-15	EA - Each	52959-535	d93260c1-4526-46f7-bdb9-e006eec04d3e	1	2012-07-24
52959-535-28	EA - Each	52959-535	fdacb51b-6136-4248-9a5e-f0b8938b16b8	1	2012-07-24
52959-535-30	EA - Each	52959-535	49f43198-99fe-41dc-a3ed-9a8871b3d16c	1	2012-07-24
52959-535-40	EA - Each	52959-535	cf30516f-b3b9-4dec-863d-6eca59d9fb39	1	2012-07-24
52959-535-60	EA - Each	52959-535	404cc9aa-051b-4024-8fb7-2db11c9bb079	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 [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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-535	STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	17	Legacy NDC	20110812_a4231f67-6c04-4ce6-8c3d-6db52afaadbe.zip
52959-535	TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.]	4	Legacy NDC, 9 package rows	20120423_2ed81194-be24-45a0-8dde-fbc6ad3d7abe.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	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	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	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
198242	temazepam 30 MG Oral Capsule	SCD	2ed81194-be24-45a0-8dde-fbc6ad3d7abe	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-535-10	52959053510	10 in 1 BOTTLE	Historical
52959-535-12	52959053512	121 in 1 BOTTLE	Historical
52959-535-15	52959053515	15 in 1 BOTTLE	Historical
52959-535-20	52959053520	20 in 1 BOTTLE	Historical
52959-535-24	52959053524	24 in 1 BOTTLE	Historical
52959-535-28	52959053528	28 in 1 BOTTLE	Historical
52959-535-30	52959053530	30 in 1 BOTTLE	Historical
52959-535-40	52959053540	40 in 1 BOTTLE	Historical
52959-535-60	52959053560	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
temazepam - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-04-19	HUMAN PRESCRIPTION DRUG LABEL	4
Strazepam	Physician Therapeutics LLC \| Novel Laboratories, Inc \| H.J. Harkins Company, Inc \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	17