NDC 0378-0751-05 - Cyclobenzaprine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0378-0751
Requested NDC: 0378-0751-05
Package NDCs from labels: 0378-0751-01, 0378-0751-10, 0378-0751-05
Manufacturer: Mylan Institutional Inc.
Effective date: 2019-12-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Cyclobenzaprine Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2015-04-24	HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine hydrochloride - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-05-16	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0751-01	EA - Each	0378-0751	b3766038-d88d-467d-9923-a885cb81f00d	1	2012-07-24
0378-0751-05	EA - Each	0378-0751	f3c61b94-c9e3-4d22-8f2c-153c637c4e8e	1	2012-07-24
0378-0751-10	EA - Each	0378-0751	5c1f13f0-e9cc-45fb-9995-0892c72035a9	1	2012-07-24
0378-0751-93	EA - Each	0378-0751	c07031c7-4186-4b83-a76d-e6bd0667d45b	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 [MYLAN PHARMACEUTICALS INC.]	11
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 143 · 2,843 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier unii: 3NXW29V3WO
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Psorinum Complex	PHOSPHORUS, SILICEA, SULPHUR, ALOE	BioActive Nutritional, Inc.	d4746927-e6d4-463d-a084-56ffc48d1e67	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Boneforce HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE	BioActive Nutritional, Inc.	d96ca52b-781d-431c-ad2a-a54fd57eb106	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210	2026-08-17	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cerebellum Thalamus A Aurm	CEREBELLUM THALAMUS A AURUM	Uriel Pharmacy Inc.	e1c395b8-9221-401f-8980-c91ff8843458	2026-08-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	CORBY, JR., TERRY L.	594443fd-8e27-4ec6-e063-6294a90a3ff0	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	53bef1ab-55c0-cc52-e063-6394a90a12b3	2026-08-17	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier unii: 3NXW29V3WO
BM BM134 DROPS	ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA	BM Private Limited	59023500-89be-cc76-e063-6294a90a6e02	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM173 DROPS	ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN	BM Private Limited	59036ca4-e7bb-bbe7-e063-6394a90a410a	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
TONMYA	CYCLOBENZAPRINE HYDROCHLORIDE	Tonix Medicines, Inc.	6fa59588-ce9b-48cf-8c5f-725a448f8571	2026-08-14	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	58e6d82b-52fd-cca3-e063-6294a90a1104	2026-08-13	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Adaptopath	ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM	Energetix Corporation	41234598-0cb5-41c2-bfbe-1c15ee9bf502	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Agri-Chord	ARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOS	Energetix Corporation	9eb50e9a-3528-4809-bd76-47d99ef03f0e	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.