Diazepam

Product NDC: 21695-264
11-digit product format: 216950264
Labeler code: 21695
Product ID: 21695-264_2d96a6cb-326f-4c04-b5d7-24d7f7c20699
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA071321
Marketing category: ANDA
Marketing start: 2009-11-09
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 5 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	21695-264		I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-02	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-10	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-12	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-15	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-20	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-30	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-45	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-60	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-264	21695-264-90	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 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	21695-264-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-264-20	`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	21695-264-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-264-20	`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	21695-264-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-264-20	`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	21695-264-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-264-20	`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	21695-264-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-264-20	`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	21695-264-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-264-20	`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
A071321-001	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	AB		1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071321-001	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	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`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	A071321-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071321-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071321-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071321-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071321-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071321-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071321-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071321-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071321-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071321-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071321-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071321-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071321-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071321-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071321-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071321-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071321-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071321-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071321-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071321-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071321-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071321-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071321-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071321-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071321-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071321-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071321-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071321-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071321-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071321-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071321-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071321-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071321-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071321-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071321-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071321-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071321-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071321-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071321-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071321-001	AB	1	`cb3db0bc1861…`

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
21695-264-02	DIAZEPAM TABLETS USP CIV Rx only
21695-264-10	DIAZEPAM TABLETS USP CIV Rx only
21695-264-12	DIAZEPAM TABLETS USP CIV Rx only
21695-264-15	DIAZEPAM TABLETS USP CIV Rx only
21695-264-20	DIAZEPAM TABLETS USP CIV Rx only
21695-264-30	DIAZEPAM TABLETS USP CIV Rx only
21695-264-45	DIAZEPAM TABLETS USP CIV Rx only
21695-264-60	DIAZEPAM TABLETS USP CIV Rx only
21695-264-90	DIAZEPAM TABLETS USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-264-02	Diazepam	2 in 1 BOTTLE	TABLET	2	1
21695-264-10	Diazepam	10 in 1 BOTTLE	TABLET	10	1
21695-264-12	Diazepam	12 in 1 BOTTLE	TABLET	12	1
21695-264-15	Diazepam	15 in 1 BOTTLE	TABLET	15	1
21695-264-20	Diazepam	20 in 1 BOTTLE	TABLET	20	1
21695-264-30	Diazepam	30 in 1 BOTTLE	TABLET	30	1
21695-264-45	Diazepam	45 in 1 BOTTLE	TABLET	45	1
21695-264-60	Diazepam	60 in 1 BOTTLE	TABLET	60	1
21695-264-90	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
21695-264-02	EA - Each	21695-264	66defdd1-3088-4d9d-bfc2-0763653c3b5b	1	2012-07-24
21695-264-10	EA - Each	21695-264	b3a479f2-7c98-4cf7-9f19-46ed478b42bd	1	2012-07-24
21695-264-12	EA - Each	21695-264	03f39246-ba2a-4d2f-bcdd-39b41fcf6e84	1	2012-07-24
21695-264-15	EA - Each	21695-264	6b126895-540f-453d-b37d-a6edd5ad2461	1	2012-07-24
21695-264-20	EA - Each	21695-264	70ee587b-e79e-453c-aaed-6ae32ee3092d	1	2012-07-24
21695-264-30	EA - Each	21695-264	ae4984bf-d7f3-468c-8c09-c5e7de4a12ce	1	2012-07-24
21695-264-45	EA - Each	21695-264	c0d5ddf1-ea2a-430e-a9b2-946facc2fc57	1	2012-07-24
21695-264-60	EA - Each	21695-264	b135cfef-83a0-4764-a1b1-aa02992f6197	1	2012-07-24
21695-264-90	EA - Each	21695-264	b79b26ac-6b09-43e1-82b4-fbf145ca3c93	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diazepam	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
Diazepam	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-264	DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 9 package rows	20100921_2d96a6cb-326f-4c04-b5d7-24d7f7c20699.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	20e08b97-bb89-4129-a228-8ad9cf35a1d3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Coupler LLC	5114ae6e-8cae-e96f-e063-6294a90a9e60	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
DIAZEPAM	DIAZEPAM	Direct_Rx	4b0c9c0a-4274-4d56-a7a4-bc497916469c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	2483426d-3782-432a-8b8d-86c06ef0de4a	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	A-S Medication Solutions	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	823093aa-d0cd-53c9-e053-2a91aa0a5235	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	8b3cc5c9-91bd-7467-e053-2a95a90a44b8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Bryant Ranch Prepack	6abedac6-5133-47b2-a0e3-e239e0a2254b	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Bryant Ranch Prepack	e8e4d5f5-3b4c-4c0f-a818-9da86389473c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	A-S Medication Solutions	af9a7906-4dca-4c1f-b16b-9b666a86b363	2024-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	87b0fbb9-0c05-4ab0-8efe-7ffcae85b868	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Proficient Rx LP	e7542d46-2586-4225-b07d-2633116bfa0a	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	bdb8feda-01c6-45bd-bd66-97196ccce70c	2019-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321

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
197589	diazePAM 10 MG Oral Tablet	PSN	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1
197590	diazePAM 2 MG Oral Tablet	PSN	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1
197591	diazePAM 5 MG Oral Tablet	PSN	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1
197589	diazepam 10 MG Oral Tablet	SCD	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1
197590	diazepam 2 MG Oral Tablet	SCD	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1
197591	diazepam 5 MG Oral Tablet	SCD	2d96a6cb-326f-4c04-b5d7-24d7f7c20699	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-264-02	21695026402	2 in 1 BOTTLE	Historical
21695-264-10	21695026410	10 in 1 BOTTLE	Historical
21695-264-12	21695026412	12 in 1 BOTTLE	Historical
21695-264-15	21695026415	15 in 1 BOTTLE	Historical
21695-264-20	21695026420	20 in 1 BOTTLE	Historical
21695-264-30	21695026430	30 in 1 BOTTLE	Historical
21695-264-45	21695026445	45 in 1 BOTTLE	Historical
21695-264-60	21695026460	60 in 1 BOTTLE	Historical
21695-264-90	21695026490	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM TABLETS USP CIV Rx only	Rebel Distributors Corp.	2010-09-15	HUMAN PRESCRIPTION DRUG LABEL	1