Label: CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-439-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0378-0751
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 16, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-439-52
MFG: 0378-0751-10
Cyclobenzaprine HCL 10 MG
30 Tablets
Rx only
Lot#: NW20750001
Exp. Date: 2/2015
Each film-coated tablet contains: Cyclobenzaprine hydrochloride, USP...10mg
Dosage: See package insert
Store at 68 to 77 degrees F.
Protect from moisture. Store in a tight, light-resistant container (See USP)
Keep out of the reach of children.
Mfg. By: Mylan Pharmaceuticals, Inc. Morgantown, WV 26505 USA Lot # 3044836
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-439(NDC:0378-0751) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE 10 mg in 30 Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code M;751 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-439-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073144 05/16/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-439)