Diazepam

Product NDC: 43353-783
11-digit product format: 433530783
Labeler code: 43353
Product ID: 43353-783_32c4f44c-dd59-4b03-b271-6e51d20dbf75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077749
Marketing category: ANDA
Marketing start: 2006-03-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-783		I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-15	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-20	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-30	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-45	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-53	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-55	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-60	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-70	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-75	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-80	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-783	43353-783-90	I	Inactivated by FDA	2026-08-03

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 5 · 252 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	43353-783-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-783-20	`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	43353-783-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-783-20	`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	43353-783-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-783-20	`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	43353-783-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-783-20	`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	43353-783-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-783-20	`cfe11265f3b6…`	`090c488252e2…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077749-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	2006-03-31
A077749-002	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	2006-03-31
A077749-003	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	2006-03-31

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 4 · 123 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	A077749-001	DIAZEPAM	2MG	TABLET / ORAL		2006-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077749-002	DIAZEPAM	5MG	TABLET / ORAL		2006-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077749-003	DIAZEPAM	10MG	TABLET / ORAL		2006-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2006-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2006-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077749-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2006-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077749-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077749-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077749-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077749-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077749-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077749-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077749-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077749-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077749-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077749-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077749-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077749-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077749-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077749-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077749-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077749-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077749-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077749-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077749-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077749-001	AB	1	`5c6f7cd8ea54…`

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
43353-783-15	DIAZEPAM TABLETS, USP
43353-783-20	DIAZEPAM TABLETS, USP
43353-783-30	DIAZEPAM TABLETS, USP
43353-783-45	DIAZEPAM TABLETS, USP
43353-783-53	DIAZEPAM TABLETS, USP
43353-783-55	DIAZEPAM TABLETS, USP
43353-783-60	DIAZEPAM TABLETS, USP
43353-783-70	DIAZEPAM TABLETS, USP
43353-783-75	DIAZEPAM TABLETS, USP
43353-783-80	DIAZEPAM TABLETS, USP
43353-783-90	DIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-783-15	Diazepam	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
43353-783-20	Diazepam	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
43353-783-30	Diazepam	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
43353-783-45	Diazepam	45 in 1 BOTTLE, PLASTIC	TABLET	45	2
43353-783-53	Diazepam	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
43353-783-55	Diazepam	75 in 1 BOTTLE, PLASTIC	TABLET	75	2
43353-783-60	Diazepam	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
43353-783-70	Diazepam	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
43353-783-75	Diazepam	150 in 1 BOTTLE, PLASTIC	TABLET	150	2
43353-783-80	Diazepam	180 in 1 BOTTLE, PLASTIC	TABLET	180	2
43353-783-90	Diazepam	240 in 1 BOTTLE, PLASTIC	TABLET	240	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-783-15	EA - Each	43353-783	42fbbde8-d410-4a81-85da-b7073dcb94ff	1	2013-05-02
43353-783-20	EA - Each	43353-783	025269a4-4673-4250-a17d-677ae7f0f38e	1	2014-04-03
43353-783-30	EA - Each	43353-783	8668c9db-87fb-427d-a7bd-abf88923706b	1	2014-04-03
43353-783-45	EA - Each	43353-783	6abd7d4c-4f73-4fdf-b47e-b5fb15f68dac	1	2013-05-02
43353-783-53	EA - Each	43353-783	9399d294-4408-4f4e-9c93-ee2e1cde109c	1	2014-04-03
43353-783-55	EA - Each	43353-783	19b98f74-aa57-4453-ae85-cfb7a42a3a1f	1	2014-04-03
43353-783-60	EA - Each	43353-783	04409c4a-8e7a-4ade-81b6-cfc57ce167c0	1	2014-04-03
43353-783-70	EA - Each	43353-783	b46c63ba-8ef5-433c-b5be-80962696f942	1	2014-04-03
43353-783-75	EA - Each	43353-783	e1938f26-176c-46af-82ef-5ae929c42962	1	2013-05-02
43353-783-80	EA - Each	43353-783	173f35f4-990f-49e9-9392-93d01b158dd6	1	2013-05-02
43353-783-90	EA - Each	43353-783	cd0ce2cf-bf49-4f55-a23f-a0bab546c5f0	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-783	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 11 package rows	20140416_1a21e393-2dd5-4c64-b5a9-f29c28453edd.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
197590	diazePAM 2 MG Oral Tablet	PSN	1a21e393-2dd5-4c64-b5a9-f29c28453edd	2
197591	diazePAM 5 MG Oral Tablet	PSN	1a21e393-2dd5-4c64-b5a9-f29c28453edd	2
197590	diazepam 2 MG Oral Tablet	SCD	1a21e393-2dd5-4c64-b5a9-f29c28453edd	2
197591	diazepam 5 MG Oral Tablet	SCD	1a21e393-2dd5-4c64-b5a9-f29c28453edd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-783-15	43353078315	15 in 1 BOTTLE, PLASTIC	Historical
43353-783-20	43353078320	20 in 1 BOTTLE, PLASTIC	Historical
43353-783-30	43353078330	30 in 1 BOTTLE, PLASTIC	Historical
43353-783-45	43353078345	45 in 1 BOTTLE, PLASTIC	Historical
43353-783-53	43353078353	60 in 1 BOTTLE, PLASTIC	Historical
43353-783-55	43353078355	75 in 1 BOTTLE, PLASTIC	Historical
43353-783-60	43353078360	90 in 1 BOTTLE, PLASTIC	Historical
43353-783-70	43353078370	120 in 1 BOTTLE, PLASTIC	Historical
43353-783-75	43353078375	150 in 1 BOTTLE, PLASTIC	Historical
43353-783-80	43353078380	180 in 1 BOTTLE, PLASTIC	Historical
43353-783-90	43353078390	240 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-04-09	HUMAN PRESCRIPTION DRUG LABEL	2