"0480-3295-56" National Drug Code (NDC)

Phentermine And Topiramate 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3295-56)
(Teva Pharmaceuticals, Inc.)

NDC Code0480-3295-56
Package Description30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3295-56)
Product NDC0480-3295
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePhentermine And Topiramate
Non-Proprietary NamePhentermine And Topiramate
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20250507
Marketing Category NameANDA
Application NumberANDA204982
ManufacturerTeva Pharmaceuticals, Inc.
Substance NamePHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Strength15; 92
Strength Unitmg/1; mg/1
Pharmacy ClassesAppetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA ScheduleCIV

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