Temazepam

Product NDC: 68071-4100
11-digit product format: 680714100
Labeler code: 68071
Product ID: 68071-4100_95aefb7c-098f-549f-e053-2995a90a5485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA071620
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 30 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68071-4100		D	Discontinued by firm	2026-08-07
excluded package	package	68071-4100	68071-4100-1	D	Discontinued by firm	2026-08-07
excluded package	package	68071-4100	68071-4100-2	D	Discontinued by firm	2026-08-07
excluded package	package	68071-4100	68071-4100-3	D	Discontinued by firm	2026-08-07
excluded package	package	68071-4100	68071-4100-6	D	Discontinued by firm	2026-08-07
excluded package	package	68071-4100	68071-4100-8	D	Discontinued by firm	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 2 · 108 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	68071-4100-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4100-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4100-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4100-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4100-8	`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	68071-4100-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4100-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4100-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4100-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4100-8	`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	68071-4100-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4100-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4100-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4100-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4100-8	`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	68071-4100-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4100-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4100-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4100-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4100-8	`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	68071-4100-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4100-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4100-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4100-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4100-8	`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	68071-4100-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4100-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4100-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4100-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4100-8	`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	68071-4100-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4100-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4100-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4100-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4100-8	`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	68071-4100-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4100-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4100-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4100-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4100-8	`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	68071-4100-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4100-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4100-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4100-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4100-8	`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	68071-4100-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4100-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4100-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4100-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4100-8	`ad56d346431e…`	`cc804d4bbf1e…`

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

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
A071620-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB		1987-08-07
A071620-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB		1987-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A071620-001	AB
A071620-002	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 3 · 82 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	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A071620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071620-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071620-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071620-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071620-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071620-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071620-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071620-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071620-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071620-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071620-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071620-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071620-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071620-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071620-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071620-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-4100-1	2024-07-25	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-2	2024-07-25	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-3	2024-07-25	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-6	2024-07-25	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-8	2024-07-25	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-1	2022-01-28	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-2	2022-01-28	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-3	2022-01-28	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-6	2022-01-28	TEMAZEPAM CAPSULES, USP CIV Rx only
68071-4100-8	2022-01-28	TEMAZEPAM CAPSULES, USP CIV Rx only

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	REMEDYREPACK INC.	85919240-0bac-4ed9-97aa-f1aa29be7ffa	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	38afa73c-7c87-440d-bece-f268e8e4a44c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620
Temazepam	TEMAZEPAM	Actavis Pharma, Inc.	a4370eb4-b00d-4247-af8d-980e59fbbec6	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620
Temazepam	TEMAZEPAM CIV	NuCare Pharmaceuticals,Inc.	617d1957-c414-7f34-e053-2a91aa0a3fe0	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620

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
68071-4100-1	68071410001	10 CAPSULE in 1 BOTTLE (68071-4100-1)	10 capsule	2018-02-07	0000-00-00	No	No	Current
68071-4100-2	68071410002	20 CAPSULE in 1 BOTTLE (68071-4100-2)	20 capsule	2018-02-07	0000-00-00	No	No	Current
68071-4100-3	68071410003	30 CAPSULE in 1 BOTTLE (68071-4100-3)	30 capsule	2018-02-07	0000-00-00	No	No	Current
68071-4100-6	68071410006	60 CAPSULE in 1 BOTTLE (68071-4100-6)	60 capsule	2018-02-07	0000-00-00	No	No	Current
68071-4100-8	68071410008	28 CAPSULE in 1 BOTTLE (68071-4100-8)	28 capsule	2018-02-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEMAZEPAM CAPSULES, USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2020-01-14	HUMAN PRESCRIPTION DRUG LABEL	2