PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet, orally disintegrating 
Zydus Lifesciences Limited

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PHENTERAMINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS

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
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)

Revised: 12/2024
Document Id: 33420a93-c8cc-4dbe-81b8-6ba67e6d6ba2
Set id: 0a1088ea-2c96-4565-aa43-28d6a98d6996
Version: 5
Effective Time: 20241203
 
Zydus Lifesciences Limited