Clonazepam

Product NDC: 0228-3003
11-digit product format: 002283003
Labeler code: 0228
Product ID: 0228-3003_9e152139-3fcf-4c44-b9b2-7110cde04d12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA074869
Marketing category: ANDA
Marketing start: 1997-02-12
Marketing end: 2022-04-30
Substance: CLONAZEPAM
Active strength: 1 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
f8e2a02d-e7b1-29aa-eb39-98a679441d91	Product name	3	20190927
dc4336d1-53d4-d410-38d3-71aa2ce4749b	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-3003-11	EA - Each	0228-3003	e2476670-a303-4a8a-95f1-3d3ab20c90d1	1	2012-07-24
0228-3003-50	EA - Each	0228-3003	edf99fd6-0836-4d57-bc7e-996f61a5a474	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	4
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [DIRECT RX]	4
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	4
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [DIRECT RX]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [DIRECT RX]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [STAT RX USA LLC]	4
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [STAT RX USA LLC]	4
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [DIRECT RX]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [DIRECT RX]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [DIRECT RX]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [STAT RX USA LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [DIRECT RX]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [STAT RX USA LLC]	4
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [UNIT DOSE SERVICES]	3
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5PE9FDE8GB	CLONAZEPAM	1622-61-3	CLONAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197527	clonazePAM 0.5 MG Oral Tablet	PSN	af2385dd-0a2d-4e64-86c8-d6616f48fb9d	10
197527	clonazepam 0.5 MG Oral Tablet	SCD	af2385dd-0a2d-4e64-86c8-d6616f48fb9d	10
197527	clonazePAM 0.5 MG Oral Tablet	PSN	7c335bb0-14ae-4eec-b093-f922130afb1f	5
197527	clonazepam 0.5 MG Oral Tablet	SCD	7c335bb0-14ae-4eec-b093-f922130afb1f	5
197527	clonazePAM 0.5 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197527	clonazePAM 0.5 MG Oral Tablet	PSN	68bf5bfa-8357-44ed-82ff-ad80a11789c5	4
197528	clonazePAM 1 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197529	clonazePAM 2 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197527	clonazepam 0.5 MG Oral Tablet	SCD	68bf5bfa-8357-44ed-82ff-ad80a11789c5	4
197527	clonazepam 0.5 MG Oral Tablet	SCD	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197528	clonazepam 1 MG Oral Tablet	SCD	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197529	clonazepam 2 MG Oral Tablet	SCD	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197527	clonazePAM 0.5 MG Oral Tablet	PSN	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197528	clonazePAM 1 MG Oral Tablet	PSN	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197529	clonazePAM 2 MG Oral Tablet	PSN	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197527	clonazepam 0.5 MG Oral Tablet	SCD	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197528	clonazepam 1 MG Oral Tablet	SCD	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197529	clonazepam 2 MG Oral Tablet	SCD	a2bc95cc-a716-44f3-b6fe-c7874aa6606f	3
197527	clonazePAM 0.5 MG Oral Tablet	PSN	1edec3f0-b6c9-1c0f-e054-00144ff8d46c	2
197527	clonazepam 0.5 MG Oral Tablet	SCD	1edec3f0-b6c9-1c0f-e054-00144ff8d46c	2
197527	clonazePAM 0.5 MG Oral Tablet	PSN	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197527	clonazePAM 0.5 MG Oral Tablet	PSN	c72fe003-6766-419f-b811-4bd7784c362c	1
197527	clonazePAM 0.5 MG Oral Tablet	PSN	ec0e596c-baca-417d-8aa4-a1878100064d	1
197528	clonazePAM 1 MG Oral Tablet	PSN	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197528	clonazePAM 1 MG Oral Tablet	PSN	ec0e596c-baca-417d-8aa4-a1878100064d	1
197529	clonazePAM 2 MG Oral Tablet	PSN	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197529	clonazePAM 2 MG Oral Tablet	PSN	ec0e596c-baca-417d-8aa4-a1878100064d	1
197527	clonazepam 0.5 MG Oral Tablet	SCD	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197527	clonazepam 0.5 MG Oral Tablet	SCD	c72fe003-6766-419f-b811-4bd7784c362c	1
197527	clonazepam 0.5 MG Oral Tablet	SCD	ec0e596c-baca-417d-8aa4-a1878100064d	1
197528	clonazepam 1 MG Oral Tablet	SCD	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197528	clonazepam 1 MG Oral Tablet	SCD	ec0e596c-baca-417d-8aa4-a1878100064d	1
197529	clonazepam 2 MG Oral Tablet	SCD	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197529	clonazepam 2 MG Oral Tablet	SCD	ec0e596c-baca-417d-8aa4-a1878100064d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-3003-11	00228300311	100 TABLET in 1 BOTTLE (0228-3003-11)	100 tablet	1997-02-12	2022-03-31	No	No	Current
0228-3003-50	00228300350	500 TABLET in 1 BOTTLE (0228-3003-50)	500 tablet	1997-02-12	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONAZEPAM TABLETS, USP	Medsource Pharmaceuticals \| Mesource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
CLONAZEPAM TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	3
CLONAZEPAM	DIRECT RX	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	5
CLONAZEPAM TABLETS, USP CIV	ATLANTIC BIOLOGICALS CORP.	2018-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
CLONAZEPAM TABLETS, USP CIV	A-S Medication Solutions	2018-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
CLONAZEPAM TABLETS, USP CIV	Unit Dose Services	2017-10-03	HUMAN PRESCRIPTION DRUG LABEL	10
CLONAZEPAM TABLETS, USP	STAT Rx USA LLC	2011-11-16	HUMAN PRESCRIPTION DRUG LABEL	4
CLONAZEPAM TABLETS, USP	H.J. Harkins Company, Inc. \| Actavis Elizabeth LLC	2011-10-11	HUMAN PRESCRIPTION DRUG LABEL	1
CLONAZEPAM TABLETS, USP CIV 40-8804 Revised — June 2009 Rx Only	Contract Pharmacy Services-PA	2010-07-01	HUMAN PRESCRIPTION DRUG LABEL	1

Clonazepam

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#