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Diclofenac Sodium - 0378-0355-05 - (diclofenac sodium)

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Drug Information of Diclofenac Sodium

Product NDC: 0378-0355
Proprietary Name: Diclofenac Sodium
Non Proprietary Name: diclofenac sodium
Active Ingredient(s): 100    mg/1 & nbsp;   diclofenac sodium
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Diclofenac Sodium

Product NDC: 0378-0355
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076152
Marketing Category: ANDA
Start Marketing Date: 20130118

Package Information of Diclofenac Sodium

Package NDC: 0378-0355-05
Package Description: 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0355-05)

NDC Information of Diclofenac Sodium

NDC Code 0378-0355-05
Proprietary Name Diclofenac Sodium
Package Description 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0355-05)
Product NDC 0378-0355
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name diclofenac sodium
Dosage Form Name TABLET, FILM COATED, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20130118
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name DICLOFENAC SODIUM
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

Complete Information of Diclofenac Sodium


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