DIAZEPAM

Product NDC: 52959-047
11-digit product format: 529590047
Labeler code: 52959
Product ID: 52959-047_75c7d502-0179-5ba1-e053-2a91aa0a7d67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA071135
Marketing category: ANDA
Marketing start: 2016-01-25
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 5 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 23 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-047		I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-00	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-01	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-02	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-03	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-04	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-05	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-06	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-10	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-12	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-14	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-15	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-20	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-21	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-23	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-24	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-25	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-30	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-40	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-45	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-50	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-60	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-047	52959-047-90	I	Inactivated by FDA	2026-10-05

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 9 · 483 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	52959-047-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-047-30	`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	52959-047-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-047-30	`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	52959-047-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-047-06	`2ef7874e63bc…`	`57b86245f4fa…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071135-001	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	AB		1987-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071135-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071135-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1987-02-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071135-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071135-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071135-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071135-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071135-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071135-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071135-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071135-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071135-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071135-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071135-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071135-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071135-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071135-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071135-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071135-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071135-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071135-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071135-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071135-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071135-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071135-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071135-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071135-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071135-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071135-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071135-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071135-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071135-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071135-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071135-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071135-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071135-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071135-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071135-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071135-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071135-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071135-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071135-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071135-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
69057c52-36b0-21c0-02d6-d697be15c03c	Product name	4	20260305
da74e203-d183-4c62-8511-c3ef56b5964e	Product name	1	20250213
2792dd44-ff30-4712-8b05-1850c2b4d307	Product name	3	20250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876	Product name	2	20250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42b	Product name	2	20240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-047-00	0047/0295/0306 DIAZEPAM
52959-047-01	0047/0295/0306 DIAZEPAM
52959-047-02	0047/0295/0306 DIAZEPAM
52959-047-03	0047/0295/0306 DIAZEPAM
52959-047-04	0047/0295/0306 DIAZEPAM
52959-047-05	0047/0295/0306 DIAZEPAM
52959-047-06	0047/0295/0306 DIAZEPAM
52959-047-10	0047/0295/0306 DIAZEPAM
52959-047-12	0047/0295/0306 DIAZEPAM
52959-047-14	0047/0295/0306 DIAZEPAM
52959-047-15	0047/0295/0306 DIAZEPAM
52959-047-20	0047/0295/0306 DIAZEPAM
52959-047-21	0047/0295/0306 DIAZEPAM
52959-047-23	0047/0295/0306 DIAZEPAM
52959-047-24	0047/0295/0306 DIAZEPAM
52959-047-25	0047/0295/0306 DIAZEPAM
52959-047-30	0047/0295/0306 DIAZEPAM
52959-047-40	0047/0295/0306 DIAZEPAM
52959-047-45	0047/0295/0306 DIAZEPAM
52959-047-50	0047/0295/0306 DIAZEPAM
52959-047-60	0047/0295/0306 DIAZEPAM
52959-047-90	0047/0295/0306 DIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-047-30	Gabavale-5	30 in 1 BOTTLE	TABLET	30	5 mg	4
52959-047-00	DIAZEPAM	100 in 1 BOTTLE	TABLET	100		1
52959-047-01	DIAZEPAM	1 in 1 BOTTLE	TABLET	1		1
52959-047-02	DIAZEPAM	120 in 1 BOTTLE	TABLET	120		1
52959-047-03	DIAZEPAM	3 in 1 BOTTLE	TABLET	3		1
52959-047-04	DIAZEPAM	4 in 1 BOTTLE	TABLET	4		1
52959-047-05	DIAZEPAM	5 in 1 BOTTLE	TABLET	5		1
52959-047-06	DIAZEPAM	6 in 1 BOTTLE	TABLET	6		1
52959-047-10	DIAZEPAM	10 in 1 BOTTLE	TABLET	10		1
52959-047-12	DIAZEPAM	12 in 1 BOTTLE	TABLET	12		1
52959-047-14	DIAZEPAM	14 in 1 BOTTLE	TABLET	14		1
52959-047-15	DIAZEPAM	15 in 1 BOTTLE	TABLET	15		1
52959-047-20	DIAZEPAM	20 in 1 BOTTLE	TABLET	20		1
52959-047-21	DIAZEPAM	21 in 1 BOTTLE	TABLET	21		1
52959-047-23	DIAZEPAM	2 in 1 BOTTLE	TABLET	2		1
52959-047-24	DIAZEPAM	24 in 1 BOTTLE	TABLET	24		1
52959-047-25	DIAZEPAM	25 in 1 BOTTLE	TABLET	25		1
52959-047-30	DIAZEPAM	30 in 1 BOTTLE	TABLET	30		1
52959-047-40	DIAZEPAM	40 in 1 BOTTLE	TABLET	40		1
52959-047-45	DIAZEPAM	45 in 1 BOTTLE	TABLET	45		1
52959-047-50	DIAZEPAM	50 in 1 BOTTLE	TABLET	50		1
52959-047-60	DIAZEPAM	60 in 1 BOTTLE	TABLET	60		1
52959-047-90	DIAZEPAM	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-047-01	EA - Each	52959-047	ca7d049d-94c5-4426-8258-1354174cb4ff	1	2018-10-11
52959-047-02	EA - Each	52959-047	89b2b5ec-3ee8-457a-8ede-74ab3efa3576	1	2018-10-11
52959-047-03	EA - Each	52959-047	ea2aa9c9-4127-4dce-a060-959a95790772	1	2018-10-11
52959-047-05	EA - Each	52959-047	29d30819-684d-472b-b336-5950d3bcb888	1	2018-10-11
52959-047-06	EA - Each	52959-047	d3b80100-ea9a-4a42-bae9-88ac95ed48d4	1	2018-10-11
52959-047-10	EA - Each	52959-047	51375bb6-53de-4679-af3d-57eb7615d583	1	2018-10-11
52959-047-12	EA - Each	52959-047	6e0ddf81-9629-4fd1-bab7-c828ba4b920f	1	2018-10-11
52959-047-15	EA - Each	52959-047	f28cc7dd-939a-4549-bc8a-f7843fb3cb5c	1	2018-10-11
52959-047-20	EA - Each	52959-047	55a7db19-5de6-439c-864d-f775189c63bf	1	2018-10-11
52959-047-21	EA - Each	52959-047	6eeb201d-fbcd-4078-b404-a3a1829ec5fe	1	2018-10-11
52959-047-25	EA - Each	52959-047	cc174afe-2598-4d31-89ac-3a601e47407a	1	2018-10-11
52959-047-30	EA - Each	52959-047	a28957aa-37b9-42f0-826a-8a675115118a	1	2018-10-11
52959-047-40	EA - Each	52959-047	a5a2644c-6eea-4f2e-825a-c359c7ab2bda	1	2018-10-11
52959-047-45	EA - Each	52959-047	a7b99a96-22a7-4be3-8f59-2f01cf9f9cc1	1	2018-10-11
52959-047-50	EA - Each	52959-047	cbd39c0c-ffb9-41fe-950a-c75e80fbe918	1	2018-10-11
52959-047-60	EA - Each	52959-047	e195f88a-56a7-485d-a4dc-9588abcfe105	1	2018-10-11
52959-047-90	EA - Each	52959-047	be27e56d-8900-4be0-a1f1-3b63c30f0b86	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-047	GABAVALE-5 (DIAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	4	Legacy NDC	20110812_188b8a95-3db7-4a6a-bddf-48b83a0c8e38.zip
52959-047	DIAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 22 package rows	20180926_75c7d502-0178-5ba1-e053-2a91aa0a7d67.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3JTX2Q7TU	DIAZEPAM	439-14-5	DIAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197591	diazePAM 5 MG Oral Tablet	PSN	188b8a95-3db7-4a6a-bddf-48b83a0c8e38	4
197591	diazepam 5 MG Oral Tablet	SCD	188b8a95-3db7-4a6a-bddf-48b83a0c8e38	4
197589	diazePAM 10 MG Oral Tablet	PSN	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1
197590	diazePAM 2 MG Oral Tablet	PSN	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1
197591	diazePAM 5 MG Oral Tablet	PSN	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1
197589	diazepam 10 MG Oral Tablet	SCD	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1
197590	diazepam 2 MG Oral Tablet	SCD	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1
197591	diazepam 5 MG Oral Tablet	SCD	75c7d502-0178-5ba1-e053-2a91aa0a7d67	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-047-00	52959004700	100 in 1 BOTTLE	Historical
52959-047-01	52959004701	1 in 1 BOTTLE	Historical
52959-047-02	52959004702	120 in 1 BOTTLE	Historical
52959-047-03	52959004703	3 in 1 BOTTLE	Historical
52959-047-04	52959004704	4 in 1 BOTTLE	Historical
52959-047-05	52959004705	5 in 1 BOTTLE	Historical
52959-047-06	52959004706	6 in 1 BOTTLE	Historical
52959-047-10	52959004710	10 in 1 BOTTLE	Historical
52959-047-12	52959004712	12 in 1 BOTTLE	Historical
52959-047-14	52959004714	14 in 1 BOTTLE	Historical
52959-047-15	52959004715	15 in 1 BOTTLE	Historical
52959-047-20	52959004720	20 in 1 BOTTLE	Historical
52959-047-21	52959004721	21 in 1 BOTTLE	Historical
52959-047-23	52959004723	2 in 1 BOTTLE	Historical
52959-047-24	52959004724	24 in 1 BOTTLE	Historical
52959-047-25	52959004725	25 in 1 BOTTLE	Historical
52959-047-30	52959004730	30 in 1 BOTTLE	Historical
52959-047-40	52959004740	40 in 1 BOTTLE	Historical
52959-047-45	52959004745	45 in 1 BOTTLE	Historical
52959-047-50	52959004750	50 in 1 BOTTLE	Historical
52959-047-60	52959004760	60 in 1 BOTTLE	Historical
52959-047-90	52959004790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0047/0295/0306 DIAZEPAM	H.J. Harkins Company, Inc.	2018-09-13	HUMAN PRESCRIPTION DRUG LABEL	1
Gabavale-5	Physician Therapeutics LLC \| TEVA Czech Industries s.r.o \| Targeted Medical Pharma Inc. \| H.J. Harkins Company, Inc	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	4