"0378-6750-05" National Drug Code (NDC)

Balsalazide Disodium 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-6750-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6750-05
Package Description500 CAPSULE in 1 BOTTLE, PLASTIC (0378-6750-05)
Product NDC0378-6750
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBalsalazide Disodium
Non-Proprietary NameBalsalazide Disodium
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20071228
Marketing Category NameANDA
Application NumberANDA077807
ManufacturerMylan Pharmaceuticals Inc.
Substance NameBALSALAZIDE DISODIUM
Strength750
Strength Unitmg/1
Pharmacy ClassesAminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]

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