Diazepam

Product NDC: 72572-140
Requested package NDC: 72572-140-02
11-digit product format: 725720140
Labeler code: 72572
Product ID: 72572-140_7c8644aa-0bb2-4573-b238-681b82933f0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIAZEPAM
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Civica, Inc.
Application: ANDA210363
Marketing category: ANDA
Marketing start: 2019-12-01
Substance: DIAZEPAM
Active strength: 10 mg/2mL
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 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
A210363-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210363-001	AP

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION		RS	2019-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210363-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	2019-03-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210363-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210363-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210363-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210363-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210363-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210363-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210363-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210363-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210363-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210363-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210363-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210363-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210363-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210363-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210363-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210363-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210363-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210363-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210363-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210363-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210363-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210363-001	AP	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A210363-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210363-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210363-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210363-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210363-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210363-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210363-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210363-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210363-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210363-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210363-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210363-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210363-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210363-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210363-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210363-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210363-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	10 mg/2mL

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
2120550	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
83646a0f-eb43-4871-b95e-683c2533d2be	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72572-140-01	Diazepam	2 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	2		7
72572-140-02	Diazepam	10 in 1 CARTON	INJECTION, SOLUTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-140-01	ML - Milliliter	72572-140	107ca922-3ade-4f2a-9eb6-f579bb8e3785	1	2020-01-03
72572-140-02	ML - Milliliter	72572-140	999cc25c-cc4e-4ed9-a34f-9cc34b0181fb	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72572-140	DIAZEPAM INJECTION, SOLUTION [CIVICA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250410_83646a0f-eb43-4871-b95e-683c2533d2be.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	c57af2a2-aa9a-4dac-a200-e0d845005d05	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363
Diazepam	DIAZEPAM	Natco Pharma USA LLC	6b8dc373-fa01-42c9-89af-4e00bf00180a	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363
Diazepam	DIAZEPAM	Natco Pharma USA LLC	a14f5930-a3ac-4996-9778-df5baa3d0bab	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363
Diazepam	DIAZEPAM	Civica, Inc.	83646a0f-eb43-4871-b95e-683c2533d2be	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210363 application number: ANDA210363 ndc (package): 72572-140-02 ndc (product): 72572-140 ndc11 (package): 72572014002

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
2120550	diazePAM 10 MG in 2 ML Prefilled Syringe	PSN	83646a0f-eb43-4871-b95e-683c2533d2be	7
2120550	2 ML diazepam 5 MG/ML Prefilled Syringe	SCD	83646a0f-eb43-4871-b95e-683c2533d2be	7
2120550	diazepam 10 MG per 2 ML Prefilled Syringe	SY	83646a0f-eb43-4871-b95e-683c2533d2be	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-140-02	72572014002	10 SYRINGE, GLASS in 1 CARTON (72572-140-02) / 2 mL in 1 SYRINGE, GLASS (72572-140-01)	2019-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
diazePAM injection, USP	Civica, Inc. \| Beloteca, Inc. \| Corden Pharma S.p.a. \| GLAND PHARMA LIMITED	2025-04-07	HUMAN PRESCRIPTION DRUG LABEL	7