Diazepam

Product NDC: 69339-137
11-digit product format: 693390137
Labeler code: 69339
Product ID: 69339-137_2a224626-a982-4a57-9ff6-8b4f69e0c4c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIAZEPAM
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Natco Pharma USA LLC
Application: ANDA211998
Marketing category: ANDA
Marketing start: 2020-07-01
Substance: DIAZEPAM
Active strength: 5 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69339-137		I	Inactivated by FDA		2026-08-17
excluded package	package	69339-137	69339-137-95	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211998-001	DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP		2019-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211998-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211998-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	2019-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211998-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211998-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211998-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211998-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211998-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211998-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211998-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211998-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211998-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211998-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211998-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211998-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211998-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211998-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211998-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211998-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211998-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211998-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211998-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211998-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211998-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211998-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211998-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211998-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211998-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211998-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211998-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211998-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211998-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211998-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211998-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211998-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211998-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211998-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211998-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211998-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211998-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211998-001	AP	1	`a50c72e98297…`

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/mL

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
309845	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
19d0e3e5-f081-4574-9f0a-e7e97a88c7a9	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69339-137-01	Diazepam	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	7
69339-137-05	Diazepam	5 in 1 CARTON	INJECTION, SOLUTION	5	7
69339-137-91	Diazepam	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	2
69339-137-95	Diazepam	5 in 1 CARTON	INJECTION, SOLUTION	5	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69339-137-91	ML - Milliliter	69339-137	072424f3-8bf6-4d6d-b8d8-2e270013131e	1	2022-11-07
69339-137-95	ML - Milliliter	69339-137	0556be41-2b7e-4602-bb13-cb3d10245207	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69339-137	DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241225_19d0e3e5-f081-4574-9f0a-e7e97a88c7a9.zip
69339-137	DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230902_5993cd06-7ce2-4c7c-9364-f7f66aafc718.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Natco Pharma USA LLC	19d0e3e5-f081-4574-9f0a-e7e97a88c7a9	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211998 application number: ANDA211998 ndc (product): 69339-137
Diazepam	DIAZEPAM	Medical Purchasing Solutions, LLC	c8e95ff5-c177-1ec3-e053-2995a90a6d78	2023-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211998 application number: ANDA211998

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
309845	diazePAM 5 MG/ML Injectable Solution	PSN	19d0e3e5-f081-4574-9f0a-e7e97a88c7a9	7
309845	diazepam 5 MG/ML Injectable Solution	SCD	19d0e3e5-f081-4574-9f0a-e7e97a88c7a9	7
309845	diazePAM 5 MG/ML Injectable Solution	PSN	5993cd06-7ce2-4c7c-9364-f7f66aafc718	2
309845	diazePAM 5 MG/ML Injectable Solution	PSN	c8e95ff5-c177-1ec3-e053-2995a90a6d78	2
309845	diazepam 5 MG/ML Injectable Solution	SCD	5993cd06-7ce2-4c7c-9364-f7f66aafc718	2
309845	diazepam 5 MG/ML Injectable Solution	SCD	c8e95ff5-c177-1ec3-e053-2995a90a6d78	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69339-137-01	69339013701	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
69339-137-05	69339013705	5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05) / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)		2020-07-01	0000-00-00	No	No	Current
69339-137-10	69339013710	10 VIAL, MULTI-DOSE in 1 CARTON (69339-137-10) > 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)		2020-07-01	0000-00-00	No	No	Current
69339-137-91	69339013791	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
69339-137-95	69339013795	5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-95) > 10 mL in 1 VIAL, MULTI-DOSE (69339-137-91)		2022-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM INJECTION, USP	Natco Pharma USA LLC \| Beloteca, Inc.	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	7
DIAZEPAM INJECTION, USP	Natco Pharma USA LLC \| Beloteca, Inc. \| Corden Pharma S.p.a.	2023-08-05	HUMAN PRESCRIPTION DRUG LABEL	2
DIAZEPAM Injection, USP 5 mg/mL	Medical Purchasing Solutions, LLC	2023-04-27	HUMAN PRESCRIPTION DRUG LABEL	2