Label: PHENTERMINE HYDROCHLORIDE tablet, orally disintegrating

  • NDC Code(s): 70771-1200-0, 70771-1200-1, 70771-1200-2, 70771-1200-3, view more
    70771-1200-4, 70771-1200-5, 70771-1200-9, 70771-1201-0, 70771-1201-1, 70771-1201-2, 70771-1201-3, 70771-1201-4, 70771-1201-5, 70771-1201-9, 70771-1202-0, 70771-1202-1, 70771-1202-2, 70771-1202-3, 70771-1202-4, 70771-1202-5, 70771-1202-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1200-1 in bottle of 100 Tablets

    Phentermine Hydrochloride Orally Disintegrating Tablets, 15 mg

    Rx only

    100 Tablets

    Phentermine hcl odtab 15mg-image 02

    NDC 70771-1201-1 in bottle of 100 Tablets

    Phentermine Hydrochloride Orally Disintegrating Tablets, 30 mg

    Rx only

    100 Tablets

    phentermine hcl odtab 30mg-image 03

    NDC 70771-1202-1 in bottle of 100 Tablets

    Phentermine Hydrochloride Orally Disintegrating Tablets, 37.5 mg

    Rx only

    100 Tablets

    phentermine hcl odtab 37.5 mg
  • INGREDIENTS AND APPEARANCE
    PHENTERMINE HYDROCHLORIDE 
    phentermine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1200
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeROUND (round) Size8mm
    FlavorPEPPERMINT (peppermint flavour) Imprint Code 703
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1200-330 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    2NDC:70771-1200-990 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    3NDC:70771-1200-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    4NDC:70771-1200-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    5NDC:70771-1200-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    6NDC:70771-1200-410 in 1 CARTON02/08/2018
    6NDC:70771-1200-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20466302/08/2018
    PHENTERMINE HYDROCHLORIDE 
    phentermine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1201
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (oval) Size14mm
    FlavorPEPPERMINT (peppermint flavour) Imprint Code 704
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1201-330 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    2NDC:70771-1201-990 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    3NDC:70771-1201-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    4NDC:70771-1201-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    5NDC:70771-1201-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    6NDC:70771-1201-410 in 1 CARTON02/08/2018
    6NDC:70771-1201-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20466302/08/2018
    PHENTERMINE HYDROCHLORIDE 
    phentermine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1202
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorPEPPERMINT (PEPPERMINT) Imprint Code 670
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1202-330 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    2NDC:70771-1202-990 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    3NDC:70771-1202-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    4NDC:70771-1202-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    5NDC:70771-1202-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    6NDC:70771-1202-410 in 1 CARTON02/08/2018
    6NDC:70771-1202-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20466302/08/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1200, 70771-1201, 70771-1202) , MANUFACTURE(70771-1200, 70771-1201, 70771-1202)
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