Diazepam

Product NDC: 0603-3215
11-digit product format: 006033215
Labeler code: 0603
Product ID: 0603-3215_20ddd338-a5bc-4107-bba7-cc3dfee47946
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Qualitest Pharmaceuticals
Application: ANDA077749
Marketing category: ANDA
Marketing start: 2006-03-31
Marketing end: 2019-08-31
Substance: DIAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-3215-02	EA - Each	0603-3215	eba1e8e9-ee61-483e-b0bf-39f39ec9ce49	1	2012-07-24
0603-3215-16	EA - Each	0603-3215	7bcdda25-46fd-4fd3-9d1b-e4282bc7228a	1	2012-07-24
0603-3215-20	EA - Each	0603-3215	8b90bb3f-2671-470e-b8fa-9528fdd7133d	1	2012-07-24
0603-3215-21	EA - Each	0603-3215	3912547e-f972-49dd-a6b9-d295d5591380	1	2012-07-24
0603-3215-22	EA - Each	0603-3215	a85f3369-d2ac-49be-b2b2-a0bd205483c6	1	2012-07-24
0603-3215-28	EA - Each	0603-3215	9166bfdd-7c15-477a-b801-718b797b3dcd	1	2012-07-24
0603-3215-32	EA - Each	0603-3215	0d923061-274a-42b7-9aa6-020de2880d50	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [STAT RX USA LLC]	3
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [STAT RX USA LLC]	3
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [STAT RX USA LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [STAT RX USA LLC]	3
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [STAT RX USA LLC]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [STAT RX USA LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [STAT RX USA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [STAT RX USA LLC]	3
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [DIRECT RX]	2
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [DIRECT RX]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [DIRECT RX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [DIRECT RX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [DISPENSING SOLUTIONS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [DIRECT RX]	2
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	1

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
197589	diazePAM 10 MG Oral Tablet	PSN	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197590	diazePAM 2 MG Oral Tablet	PSN	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197591	diazePAM 5 MG Oral Tablet	PSN	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197589	diazepam 10 MG Oral Tablet	SCD	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197590	diazepam 2 MG Oral Tablet	SCD	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197591	diazepam 5 MG Oral Tablet	SCD	169f4b44-ec42-4fa5-8a22-672cef833c0f	18
197589	diazePAM 10 MG Oral Tablet	PSN	a24ddeff-b47f-48c9-aa29-5ea7ef20b3be	9
197591	diazePAM 5 MG Oral Tablet	PSN	a24ddeff-b47f-48c9-aa29-5ea7ef20b3be	9
197589	diazepam 10 MG Oral Tablet	SCD	a24ddeff-b47f-48c9-aa29-5ea7ef20b3be	9
197591	diazepam 5 MG Oral Tablet	SCD	a24ddeff-b47f-48c9-aa29-5ea7ef20b3be	9
197589	diazePAM 10 MG Oral Tablet	PSN	0952dd80-819c-424e-9a82-eb161c02af4d	4
197589	diazepam 10 MG Oral Tablet	SCD	0952dd80-819c-424e-9a82-eb161c02af4d	4
197589	diazePAM 10 MG Oral Tablet	PSN	d33b6027-2adf-476f-9647-d6306415261a	3
197590	diazePAM 2 MG Oral Tablet	PSN	d33b6027-2adf-476f-9647-d6306415261a	3
197591	diazePAM 5 MG Oral Tablet	PSN	d33b6027-2adf-476f-9647-d6306415261a	3
197589	diazepam 10 MG Oral Tablet	SCD	d33b6027-2adf-476f-9647-d6306415261a	3
197590	diazepam 2 MG Oral Tablet	SCD	d33b6027-2adf-476f-9647-d6306415261a	3
197591	diazepam 5 MG Oral Tablet	SCD	d33b6027-2adf-476f-9647-d6306415261a	3
197589	diazePAM 10 MG Oral Tablet	PSN	c7bcabfd-596d-4204-a560-f75caa250249	2
197589	diazepam 10 MG Oral Tablet	SCD	c7bcabfd-596d-4204-a560-f75caa250249	2
197589	diazePAM 10 MG Oral Tablet	PSN	8155c4ef-4ec3-448b-bd60-9b78ad64b53a	1
197589	diazePAM 10 MG Oral Tablet	PSN	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1
197589	diazePAM 10 MG Oral Tablet	PSN	52e65341-5fee-4337-be5d-4da91a18f9ac	1
197590	diazePAM 2 MG Oral Tablet	PSN	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1
197591	diazePAM 5 MG Oral Tablet	PSN	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1
197589	diazepam 10 MG Oral Tablet	SCD	52e65341-5fee-4337-be5d-4da91a18f9ac	1
197589	diazepam 10 MG Oral Tablet	SCD	8155c4ef-4ec3-448b-bd60-9b78ad64b53a	1
197589	diazepam 10 MG Oral Tablet	SCD	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1
197590	diazepam 2 MG Oral Tablet	SCD	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1
197591	diazepam 5 MG Oral Tablet	SCD	d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM	DIRECT RX	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	4
DIAZEPAM TABLETS, USP	A-S Medication Solutions	2017-10-05	HUMAN PRESCRIPTION DRUG LABEL	18
DIAZEPAM TABLETS, USP	A-S Medication Solutions	2017-10-05	HUMAN PRESCRIPTION DRUG LABEL	9
DIAZEPAM TABLETS, USP	Aidarex Pharmaceuticals LLC	2013-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
DIAZEPAM TABLETS, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-11-07	HUMAN PRESCRIPTION DRUG LABEL	2
DIAZEPAM TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2013-04-26	HUMAN PRESCRIPTION DRUG LABEL	1
DIAZEPAM TABLETS, USP	Blenheim Pharmacal, Inc.	2011-06-09	HUMAN PRESCRIPTION DRUG LABEL	1
DIAZEPAM - STAT RX USA LLC	STAT RX USA LLC	2010-02-22	HUMAN PRESCRIPTION DRUG LABEL	3

Diazepam

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#