Diazepam

Product NDC: 68999-767
Requested package NDC: 68999-767-24
11-digit product format: 689990767
Labeler code: 68999
Product ID: 68999-767_433f5cb2-eae0-c144-e063-6294a90a9cd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell Governmental & Specialty RX, LLC.
Application: ANDA206477
Marketing category: ANDA
Marketing start: 2016-06-24
Substance: DIAZEPAM
Active strength: 5 mg/5mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A206477-001	DIAZEPAM	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA		2016-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206477-001	AA

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	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206477-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	2016-06-24	`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	A206477-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206477-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206477-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206477-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206477-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206477-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206477-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206477-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206477-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206477-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206477-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206477-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206477-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206477-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206477-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206477-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206477-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206477-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206477-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206477-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206477-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206477-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206477-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206477-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206477-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206477-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206477-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206477-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206477-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206477-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206477-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206477-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206477-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206477-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206477-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206477-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206477-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206477-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206477-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206477-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diazepam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3JTX2Q7TU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309843	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
167ee280-be68-4a28-a7d8-de41df14bc48	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68999-767-24	Diazepam	10 in 1 TRAY	SOLUTION	10	1
68999-767-24	Diazepam	2 in 1 BOX	SOLUTION	2	1
68999-767-45	Diazepam	5 mL in 1 CUP	SOLUTION	5	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68999-767-24	ML - Milliliter	68999-767	3c442dbd-63fa-4d86-9be8-411d0362bb80	1	2026-02-05
68999-767-45	ML - Milliliter	68999-767	bf293dc7-4c5d-43ef-9d65-31662585a5e0	1	2026-02-05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM ORAL	Chartwell RX, LLC	cdb839fb-27e5-4a11-aed6-da0a7ab6e996	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206477 application number: ANDA206477
Diazepam	DIAZEPAM ORAL	Chartwell Governmental & Specialty RX, LLC.	167ee280-be68-4a28-a7d8-de41df14bc48	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206477 application number: ANDA206477 ndc (package): 68999-767-24 ndc (product): 68999-767 ndc11 (package): 68999076724

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
309843	diazePAM 5 MG in 5 mL Oral Solution	PSN	167ee280-be68-4a28-a7d8-de41df14bc48	1
309843	diazepam 1 MG/ML Oral Solution	SCD	167ee280-be68-4a28-a7d8-de41df14bc48	1
309843	diazepam 5 MG per 5 ML Oral Solution	SY	167ee280-be68-4a28-a7d8-de41df14bc48	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68999-767-24	68999076724	2 TRAY in 1 BOX (68999-767-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-767-45)	2 tray	2025-10-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Oral Solution, CIV, 5 mg per 5 mL Rx Only	Chartwell Governmental & Specialty RX, LLC.	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	1