Temazepam

Product NDC: 68788-6904
11-digit product format: 687886904
Labeler code: 68788
Product ID: 68788-6904_25483b41-d84a-4eb2-9e86-56d0c58649d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA203482
Marketing category: ANDA
Marketing start: 2017-02-28
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 30 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-6904		I	Inactivated by FDA	2026-08-11
excluded package	package	68788-6904	68788-6904-1	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-6904	68788-6904-3	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-6904	68788-6904-6	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-6904	68788-6904-8	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-6904	68788-6904-9	I	Inactivated by FDA	2026-08-11

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 3 · 132 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	68788-6904-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6904-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6904-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6904-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6904-6	`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	68788-6904-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6904-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6904-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6904-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6904-6	`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	68788-6904-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6904-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6904-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6904-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-6904-6	`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	68788-6904-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6904-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6904-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6904-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-6904-6	`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	68788-6904-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6904-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6904-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6904-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-6904-6	`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	68788-6904-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6904-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6904-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6904-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-6904-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6904-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6904-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6904-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6904-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-6904-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6904-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6904-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6904-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6904-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-6904-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6904-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6904-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6904-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6904-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-6904-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6904-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6904-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6904-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6904-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-6904-6	`ad56d346431e…`	`cc804d4bbf1e…`

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…`

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
68788-6904-1	Temazepam Capsules, USP C-IV Rx only
68788-6904-3	Temazepam Capsules, USP C-IV Rx only
68788-6904-6	Temazepam Capsules, USP C-IV Rx only
68788-6904-8	Temazepam Capsules, USP C-IV Rx only
68788-6904-9	Temazepam Capsules, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-6904-1	Temazepam	100 in 1 BOTTLE	CAPSULE	100	1
68788-6904-3	Temazepam	30 in 1 BOTTLE	CAPSULE	30	1
68788-6904-6	Temazepam	60 in 1 BOTTLE	CAPSULE	60	1
68788-6904-8	Temazepam	28 in 1 BOTTLE	CAPSULE	28	1
68788-6904-9	Temazepam	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6904	TEMAZEPAM CAPSULE [PREFERRED PHARMACEUTICALS INC.]	1	Legacy NDC, 5 package rows	20170303_25483b41-d84a-4eb2-9e86-56d0c58649d9.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
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
198242	temazepam 30 MG Oral Capsule	PSN	25483b41-d84a-4eb2-9e86-56d0c58649d9	1
198242	temazepam 30 MG Oral Capsule	SCD	25483b41-d84a-4eb2-9e86-56d0c58649d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-6904-1	68788690401	100 in 1 BOTTLE	Historical
68788-6904-3	68788690403	30 in 1 BOTTLE	Historical
68788-6904-6	68788690406	60 in 1 BOTTLE	Historical
68788-6904-8	68788690408	28 in 1 BOTTLE	Historical
68788-6904-9	68788690409	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules, USP C-IV Rx only	Preferred Pharmaceuticals Inc.	2017-02-28	HUMAN PRESCRIPTION DRUG LABEL	1