Diazepam

Product NDC: 68999-767
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 68999-767

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

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
68999-767-45	68999076745	5 mL in 1 CUP	5 ml				Historical

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