Cyclobenzaprine Hydrochloride

Product NDC: 65162-541
11-digit product format: 651620541
Labeler code: 65162
Product ID: 65162-541_df260758-80f8-4668-884c-7fb21600db2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA078218
Marketing category: ANDA
Marketing start: 2010-02-18
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclobenzaprine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	0VE05JYS2P
Rxcui	828320, 828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51048710-225c-aa41-d0e7-eed095d02838	Product name	4	20250331
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-541-10	2021-01-28	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-541-11	2021-01-28	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-541-50	2021-01-28	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-541-10	2020-01-31	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-541-11	2020-01-31	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-541-50	2020-01-31	C162847	48780-1	9d75b9d1-01bf-f424-e053-dadaa90a57ce	Cyclobenzaprine Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-541-10	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
65162-541-11	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13
65162-541-50	Cyclobenzaprine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-541-10	EA - Each	65162-541	a7550d3c-ac71-4618-8b42-ab83d3b25e04	1	2012-07-24
65162-541-11	EA - Each	65162-541	14fc0356-dd0f-4cc7-b56f-d2bbf95297d1	1	2012-07-24
65162-541-50	EA - Each	65162-541	fa6f7308-1839-448c-88f1-3b2af98ad353	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]	5
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	3
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-541	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]	13	Current NDC, Legacy NDC, 3 package rows	20241027_390151d4-5fcb-46e2-92e6-de184827f43d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	390151d4-5fcb-46e2-92e6-de184827f43d	13
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	390151d4-5fcb-46e2-92e6-de184827f43d	13
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	390151d4-5fcb-46e2-92e6-de184827f43d	13
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	390151d4-5fcb-46e2-92e6-de184827f43d	13
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	ad306e55-6c89-4d14-a553-2ac776b4dd28	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	ad306e55-6c89-4d14-a553-2ac776b4dd28	5
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	50aa421f-1d73-4b43-8528-2617ef2507dc	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	50aa421f-1d73-4b43-8528-2617ef2507dc	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	7b9f9a11-74e6-4198-965d-78ea36c9cec9	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	fae7e4a7-ca63-4af4-a43a-c5d85cce1961	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	f4fee702-2561-4317-b219-23d4543f2c75	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	c108987e-f1f9-4f0e-893a-fb036af0ce08	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	a4187ac9-cdef-4a65-8966-e329acbe9ee2	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	54a6b01c-5a7c-4710-93fa-69fd2c2549e3	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	0e185b89-d7cc-477f-ab8c-7c6f44e5c9e7	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	a4187ac9-cdef-4a65-8966-e329acbe9ee2	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	0e185b89-d7cc-477f-ab8c-7c6f44e5c9e7	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	7b9f9a11-74e6-4198-965d-78ea36c9cec9	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	c108987e-f1f9-4f0e-893a-fb036af0ce08	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	54a6b01c-5a7c-4710-93fa-69fd2c2549e3	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	f4fee702-2561-4317-b219-23d4543f2c75	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	fae7e4a7-ca63-4af4-a43a-c5d85cce1961	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-541-10	65162054110	100 TABLET, FILM COATED in 1 BOTTLE (65162-541-10)	2010-02-18	0000-00-00	No	No	Current
65162-541-11	65162054111	1000 TABLET, FILM COATED in 1 BOTTLE (65162-541-11)	2010-02-18	0000-00-00	No	No	Current
65162-541-50	65162054150	500 TABLET, FILM COATED in 1 BOTTLE (65162-541-50)	2010-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets, USP Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2024-10-24	HUMAN PRESCRIPTION DRUG LABEL	13
Cyclobenzaprine Hydrochloride Tablets, USP	Proficient Rx LP	2019-12-01	HUMAN PRESCRIPTION DRUG LABEL	4
Cyclobenzaprine Hydrochloride Tablets, USP	RxChange Co.	2014-11-06	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	ReadyMeds	2014-05-15	HUMAN PRESCRIPTION DRUG LABEL	5
Cyclobenzaprine Hydrochloride Tablets, USP	Aidarex Pharmaceuticals LLC	2013-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	STAT Rx USA LLC	2011-09-23	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	RedPharm Drug Inc. \| Amneal Pharmaceuticals	2011-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	State of Florida DOH Central Pharmacy	2010-05-21	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	Blenheim Pharmacal, Inc.	2010-04-21	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets, USP	Rebel Distributors \| Rebel Distributors.	2010-02-18	HUMAN PRESCRIPTION DRUG LABEL	1

Cyclobenzaprine Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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#