Clonazepam

Product NDC: 0228-3004
11-digit product format: 002283004
Labeler code: 0228
Product ID: 0228-3004_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: 2022-05-31
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
0228-3004-11	EA - Each	0228-3004	759981e3-8b53-4c44-b032-3c1e4b3c7e5d	1	2012-07-24
0228-3004-50	EA - Each	0228-3004	207f7c4b-9cce-41ab-9312-a6d129f49739	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	4
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	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 YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [STAT RX USA LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [STAT RX USA LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [STAT RX USA LLC]	4
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 [H.J. HARKINS COMPANY, INC.]	1
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	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 [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	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 [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	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 [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [STAT RX USA LLC]	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
197528	clonazePAM 1 MG Oral Tablet	PSN	42bb0dbb-689d-4ce8-8bfa-889f47ff31c9	5
197528	clonazepam 1 MG Oral Tablet	SCD	42bb0dbb-689d-4ce8-8bfa-889f47ff31c9	5
197527	clonazePAM 0.5 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197528	clonazePAM 1 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197528	clonazePAM 1 MG Oral Tablet	PSN	dd29b11f-797a-4d05-a564-8d73d1ea93e0	4
197529	clonazePAM 2 MG Oral Tablet	PSN	ae7bbf44-c5af-4bda-bc22-2388498ad529	4
197529	clonazePAM 2 MG Oral Tablet	PSN	dd29b11f-797a-4d05-a564-8d73d1ea93e0	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
197528	clonazepam 1 MG Oral Tablet	SCD	dd29b11f-797a-4d05-a564-8d73d1ea93e0	4
197529	clonazepam 2 MG Oral Tablet	SCD	dd29b11f-797a-4d05-a564-8d73d1ea93e0	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	52a03dbc-0510-40ec-8a33-15bf1c404622	1
197527	clonazePAM 0.5 MG Oral Tablet	PSN	ec0e596c-baca-417d-8aa4-a1878100064d	1
197528	clonazePAM 1 MG Oral Tablet	PSN	34fd5bee-5fbe-418b-831b-0a338656a43e	1
197528	clonazePAM 1 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	ff316953-15c5-434d-abbf-7b675492e2cc	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	ec0e596c-baca-417d-8aa4-a1878100064d	1
197528	clonazepam 1 MG Oral Tablet	SCD	ff316953-15c5-434d-abbf-7b675492e2cc	1
197528	clonazepam 1 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	34fd5bee-5fbe-418b-831b-0a338656a43e	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
0228-3004-11	00228300411	100 TABLET in 1 BOTTLE (0228-3004-11)	100 tablet	1997-02-12	2021-07-31	No	No	Current
0228-3004-50	00228300450	500 TABLET in 1 BOTTLE (0228-3004-50)	500 tablet	1997-02-12	2022-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONAZEPAM TABLETS, USP CIV	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL	1
CLONAZEPAM TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	3
CLONAZEPAM TABLETS, USP CIV	A-S Medication Solutions	2018-08-08	HUMAN PRESCRIPTION DRUG LABEL	5
CLONAZEPAM C-IV TABLETS - 1MG	STAT Rx USA LLC \| PSS World Medical Inc.	2012-04-19	HUMAN PRESCRIPTION DRUG LABEL	1
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	TYA Pharmaceuticals	2010-10-10	HUMAN PRESCRIPTION DRUG LABEL	4
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#