Diazepam

Product NDC: 17856-3188
Requested package NDC: 17856-3188-4
11-digit product format: 178563188
Labeler code: 17856
Product ID: 17856-3188_8fdd853b-41bf-4474-87db-e86cb2bfd21a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA070928
Marketing category: ANDA
Marketing start: 1987-04-03
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 5 mg/5mL
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-3188	17856-3188-4	I	Inactivated by FDA		2026-08-10

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 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A070928-001	DIAZEPAM	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070928-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`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	A070928-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	AA	1	`cb3db0bc1861…`

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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
17856-3188-1	2026-01-29	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-3	2026-01-29	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-4	2026-01-29	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-1	2024-05-20	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-3	2024-05-20	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-4	2024-05-20	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-1	2022-01-28	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-3	2022-01-28	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-4	2022-01-28	d6a99b39-fea7-a426-e053-dadaa90af4c2	Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-2	2020-01-31	9d75b9cf-d985-f424-e053-dadaa90a57ce	DIAZEPAM ORAL SOLUTION, CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-3188-1	Diazepam	0.8 mL in 1 SYRINGE	SOLUTION	0.8	4
17856-3188-1	Diazepam	60 in 1 BOX, UNIT-DOSE	SOLUTION	60	4
17856-3188-3	Diazepam	120 in 1 BOX, UNIT-DOSE	SOLUTION	120	4
17856-3188-3	Diazepam	0.8 mL in 1 SYRINGE	SOLUTION	0.8	4
17856-3188-4	Diazepam	72 in 1 BOX, UNIT-DOSE	SOLUTION	72	4
17856-3188-4	Diazepam	5.0 mL in 1 CUP, UNIT-DOSE	SOLUTION	5.0	4
17856-3188-2	Diazepam	2 mL in 1 CUP	SOLUTION	2	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-3188	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORP.]	4	Legacy NDC, 6 package rows	20240522_e435e56f-e6eb-4fe9-9a8f-e11527778fc1.zip
17856-3188	DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]	1	Legacy NDC, 1 package rows	20110916_5051e98b-3817-61aa-dba8-bd8be2f0c086.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	Precision Dose Inc.	78d5a77d-5ca7-4f16-b4d0-fce86456593c	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	9e85abed-1a8b-4762-a31f-f2c7f196b8af	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	American Health Packaging	aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	Pharmaceutical Associates, Inc.	b24f1eb7-3dab-4183-b81f-f86ac62aedd8	2021-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928

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	e435e56f-e6eb-4fe9-9a8f-e11527778fc1	4
309843	diazepam 1 MG/ML Oral Solution	SCD	e435e56f-e6eb-4fe9-9a8f-e11527778fc1	4
309843	diazepam 5 MG per 5 ML Oral Solution	SY	e435e56f-e6eb-4fe9-9a8f-e11527778fc1	4
309843	diazePAM 5 MG in 5 mL Oral Solution	PSN	5051e98b-3817-61aa-dba8-bd8be2f0c086	1
309843	diazepam 1 MG/ML Oral Solution	SCD	5051e98b-3817-61aa-dba8-bd8be2f0c086	1
309843	diazepam 5 MG per 5 ML Oral Solution	SY	5051e98b-3817-61aa-dba8-bd8be2f0c086	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-3188-4	17856318804	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-3188-4) > 5 mL in 1 CUP, UNIT-DOSE	2020-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam	ATLANTIC BIOLOGICALS CORP.	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	4
DIAZEPAM ORAL SOLUTION, CIV	Atlantic Biologicals Corps \| Unit Dose Services	1987-04-03	HUMAN PRESCRIPTION DRUG LABEL	1