Temazepam

Product NDC: 50436-4628
11-digit product format: 504364628
Labeler code: 50436
Product ID: 50436-4628_42cb6326-8341-47a6-82cd-f66c44ab95ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temazepam
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA071620
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: TEMAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-4628		I	Inactivated by FDA	2026-08-07
excluded package	package	50436-4628	50436-4628-1	D	Discontinued by firm	2026-08-07
excluded package	package	50436-4628	50436-4628-2	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 · 50 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	50436-4628-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-4628-1	D	Discontinued by firm	`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	50436-4628-2	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	50436-4628-2	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	50436-4628-2	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	50436-4628-2	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	50436-4628-2	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	50436-4628-2	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	50436-4628-2	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3aa44f1-a660-94b4-7185-b48df8b066ff	Product name	5	20250522
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-4628-1	2021-01-29	C162847	48780-1	ba0f9c33-5976-a910-e053-dadaa90a0b85	Temazepam Capsules, USP CIV Rx only
50436-4628-2	2021-01-29	C162847	48780-1	ba0f9c33-5976-a910-e053-dadaa90a0b85	Temazepam Capsules, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-4628-1	Temazepam	60 in 1 BOTTLE	CAPSULE	60		13
50436-4628-2	Temazepam	30 in 1 BOTTLE	CAPSULE	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-4628-1	EA - Each	50436-4628	244fc3cf-ed7f-4db7-a65d-b0b94a2c4385	1	2013-04-01
50436-4628-2	EA - Each	50436-4628	f8555f72-2943-495b-bf4e-0110e063300f	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TEMAZEPAM	ACTIVE INGREDIENT	CHB1QD2QSS	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
TEMAZEPAM	ACTIVE MOIETY	CHB1QD2QSS	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-4628	TEMAZEPAM (TEMAZEPAM) CAPSULE [UNIT DOSE SERVICES]	13	Legacy NDC, 2 package rows	20190531_dbd39517-62f5-44b0-844f-e1cbf3c6ca2e.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198241	temazepam 15 MG Oral Capsule	PSN	dbd39517-62f5-44b0-844f-e1cbf3c6ca2e	13
198241	temazepam 15 MG Oral Capsule	SCD	dbd39517-62f5-44b0-844f-e1cbf3c6ca2e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-4628-1	50436462801	60 in 1 BOTTLE	Historical
50436-4628-2	50436462802	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temazepam Capsules, USP CIV Rx only	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	13