Diazepam

Product NDC: 0378-0271
11-digit product format: 003780271
Labeler code: 0378
Product ID: 0378-0271_983a3fdc-04ca-4621-a57c-56ad36015d36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA070325
Marketing category: ANDA
Marketing start: 1985-09-04
Substance: DIAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Diazepam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	Q3JTX2Q7TU
Rxcui	197589, 197590, 197591

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-0271-01	Diazepam	100 in 1 BOTTLE, PLASTIC	TABLET	100		15
0378-0271-05	Diazepam	500 in 1 BOTTLE, PLASTIC	TABLET	500		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0271-01	EA - Each	0378-0271	3813c848-87aa-4eb3-803e-e77a86e2240a	1	2012-07-24
0378-0271-05	EA - Each	0378-0271	038c5bc2-8a29-4284-8ea3-14e1c906db5c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	5
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0271	DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240328_c397a9da-862f-4f3f-8109-7d21691de53a.zip

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
197590	diazePAM 2 MG Oral Tablet	PSN	632d7e96-d32c-45b8-86cf-f18ec2b35485	102
197590	diazepam 2 MG Oral Tablet	SCD	632d7e96-d32c-45b8-86cf-f18ec2b35485	102
197589	diazePAM 10 MG Oral Tablet	PSN	b326c66d-5762-4d16-933c-619fa2088ccd	18
197590	diazePAM 2 MG Oral Tablet	PSN	b326c66d-5762-4d16-933c-619fa2088ccd	18
197591	diazePAM 5 MG Oral Tablet	PSN	b326c66d-5762-4d16-933c-619fa2088ccd	18
197589	diazepam 10 MG Oral Tablet	SCD	b326c66d-5762-4d16-933c-619fa2088ccd	18
197590	diazepam 2 MG Oral Tablet	SCD	b326c66d-5762-4d16-933c-619fa2088ccd	18
197591	diazepam 5 MG Oral Tablet	SCD	b326c66d-5762-4d16-933c-619fa2088ccd	18
197589	diazePAM 10 MG Oral Tablet	PSN	c397a9da-862f-4f3f-8109-7d21691de53a	15
197590	diazePAM 2 MG Oral Tablet	PSN	c397a9da-862f-4f3f-8109-7d21691de53a	15
197591	diazePAM 5 MG Oral Tablet	PSN	c397a9da-862f-4f3f-8109-7d21691de53a	15
197589	diazepam 10 MG Oral Tablet	SCD	c397a9da-862f-4f3f-8109-7d21691de53a	15
197590	diazepam 2 MG Oral Tablet	SCD	c397a9da-862f-4f3f-8109-7d21691de53a	15
197591	diazepam 5 MG Oral Tablet	SCD	c397a9da-862f-4f3f-8109-7d21691de53a	15
197590	diazePAM 2 MG Oral Tablet	PSN	01f04ee4-fff9-499a-8213-984e16368084	13
197590	diazepam 2 MG Oral Tablet	SCD	01f04ee4-fff9-499a-8213-984e16368084	13
197589	diazePAM 10 MG Oral Tablet	PSN	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197590	diazePAM 2 MG Oral Tablet	PSN	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197591	diazePAM 5 MG Oral Tablet	PSN	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197589	diazepam 10 MG Oral Tablet	SCD	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197590	diazepam 2 MG Oral Tablet	SCD	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197591	diazepam 5 MG Oral Tablet	SCD	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2
197590	diazePAM 2 MG Oral Tablet	PSN	2047f721-6a05-c391-e063-6394a90a4ed7	1
197590	diazepam 2 MG Oral Tablet	SCD	2047f721-6a05-c391-e063-6394a90a4ed7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0271-01	00378027101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0271-01)	100 tablet	1985-09-04	0000-00-00	No	No	Current
0378-0271-05	00378027105	500 TABLET in 1 BOTTLE, PLASTIC (0378-0271-05)	500 tablet	1985-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	Safecor Health, LLC	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	2
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	A-S Medication Solutions	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	13
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	18
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	102
Diazepam	Direct_rx	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	1
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	Mylan Pharmaceuticals Inc.	2023-04-04	HUMAN PRESCRIPTION DRUG LABEL	15

Diazepam

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#