NDC | 64038-131-60, 64038-313-04, 64038-325-03 |
Set ID | ca38d5da-07f9-4b37-b69f-bc501a197914 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Living Well Pharmacy, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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DESCRIPTION
- RX Only
For Prescription Compounding Only
Cyclo/Mag Kit
Cyclobenzaprine HCl and Magnesium Oxide Compound Kit
Description
Each Cyclo/Mag Kit is comprised of 3 grams of cyclobenzaprine hydrochloride powder, USP and
60 grams of magnesium oxide heavy powder.
Certificate of Analysis on File
Cyclo/Mag Kit also contains 60 grams of Lactose Monohydrate (Spray dried) powder and 0.15 grams of
riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300
capsules each capsule containing 10mg of cyclobenzaprine and 200mg of magnesium oxide. -
INDICATIONS & USAGE
Equipment
Required supplies needed to compound this kit
Equipment Item Quantity Cyclobenzaprine HCl (Included) 3 grams Magnesium Oxide Heavy Powder (Included) 60 grams Lactose Monohydrate Spray Dried Powder ( Included) 60 grams Riboflavin Powder (Included) 0.15 grams Red 1 Capsules ( Required Not Included) 300 Capsules - DRUG & OR LABORATORY TEST INTERACTIONS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CYCLO/MAG
cyclobenzaprine hydrochloride, magnesium oxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64038-313 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64038-313-04 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 3 g Part 2 1 BOTTLE 60 g Part 1 of 2 CYCLOBENZAPRINE HCL
cyclobenzaprine hydrochloride powderProduct Information Item Code (Source) NDC:64038-325 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64038-325-03 3 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/03/2010 Part 2 of 2 MAGNESIUM OXIDE
magnesium oxide powderProduct Information Item Code (Source) NDC:64038-131 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM OXIDE - UNII:3A3U0GI71G) MAGNESIUM OXIDE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64038-131-60 60 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/03/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/03/2010 Labeler - Living Well Pharmacy, Inc. (070488957) Registrant - Living Well Pharmacy, Inc. (070488957) Establishment Name Address ID/FEI Business Operations Living Well Pharmacy, Inc. 070488957 repack Establishment Name Address ID/FEI Business Operations Apotheca Supply 859501871 api manufacture Establishment Name Address ID/FEI Business Operations Spectrum Laboratory Products, Inc. 075295246 api manufacture