Cyclobenzaprine Hydrochloride

Product NDC: 0591-3256
11-digit product format: 005913256
Labeler code: 0591
Product ID: 0591-3256_13578288-1fa1-4710-91a0-6e3026156d91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA071611
Marketing category: ANDA
Marketing start: 2006-02-03
Marketing end: 0000-00-00
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51048710-225c-aa41-d0e7-eed095d02838	Product name	4	20250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	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
0591-3256-01	EA - Each	0591-3256	15f46bb2-1803-47d4-ab4a-88c7bf4d8e10	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 [STAT RX USA LLC]	3
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	3
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

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	59500ba3-b16e-46f9-a867-6c54f1f8fd6a	3
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	59500ba3-b16e-46f9-a867-6c54f1f8fd6a	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	59500ba3-b16e-46f9-a867-6c54f1f8fd6a	3
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	59500ba3-b16e-46f9-a867-6c54f1f8fd6a	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	220ebc47-d310-4668-8b51-47a4981b46ef	2
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	220ebc47-d310-4668-8b51-47a4981b46ef	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	220ebc47-d310-4668-8b51-47a4981b46ef	2
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	220ebc47-d310-4668-8b51-47a4981b46ef	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	4eddf137-fd00-43d0-96ed-16f057806d4e	1
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	4eddf137-fd00-43d0-96ed-16f057806d4e	1
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	62f5bba6-23dd-47cd-9786-61be07646da7	1
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	c68204a7-d00c-4ce7-bfda-bff58b2ed67e	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	4eddf137-fd00-43d0-96ed-16f057806d4e	1
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	4eddf137-fd00-43d0-96ed-16f057806d4e	1
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	62f5bba6-23dd-47cd-9786-61be07646da7	1
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	c68204a7-d00c-4ce7-bfda-bff58b2ed67e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3256-01	00591325601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3256-01)	2006-02-03	2022-05-31	No	No	Current
0591-3256-10	00591325610	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3256-10)	2006-02-03	0000-00-00	No	No	Current
0591-3256-30	00591325630	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3256-30)	2006-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets, USP Revised: August 2016 Rx Only	RPK Pharmaceuticals, Inc.	2020-12-21	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets USP Revised: April 2005 Rx only	STAT Rx USA LLC	2012-01-23	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HYDROCHLORIDE - STAT RX USA LLC	STAT RX USA LLC	2011-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets USP Rx only	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-07-12	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-04	HUMAN PRESCRIPTION DRUG LABEL	1

Cyclobenzaprine Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#