NDC Code(s) : 10702-025-03, 10702-025-01, 10702-025-10, 10702-029-03, 10702-029-01, 10702-029-10
Packager : KVK-TECH, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Phentermine HydrochloridePhentermine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-025
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV)
(PHENTERMINE - UNII:C045TQL4WP) 		PHENTERMINE HYDROCHLORIDE37.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white, blue (SPECKLES) Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code K;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-025-0330 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
2NDC:10702-025-01100 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
3NDC:10702-025-101000 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040876 08/15/2012
Phentermine HydrochloridePhentermine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-029
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV)
(PHENTERMINE - UNII:C045TQL4WP) 		PHENTERMINE HYDROCHLORIDE37.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white, blue Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code K;29
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10702-029-0330 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
2NDC:10702-029-01100 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
3NDC:10702-029-101000 in 1 BOTTLE Type 0: Not a Combination Product15/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040887 08/15/2012

LABELER - KVK-TECH, Inc.(173360061)

REGISTRANT - KVK-Tech, Inc.(173360061)

Establishment
Name Address ID/FEI Business Operations
KVK-Tech, Inc. 173360061 manufacture(10702-025, 10702-029)

PRINCIPAL DISPLAY PANEL

Pack Size: 30s

NDC 10702- 029-03

PHENTERMINE HYDROCHLORIDE CAPSULES, USP

37.5 mg

30 CAPSULES

Rx Only

KVK-TECH, INC.

caps 30s

Pack Size: 100s

NDC 10702- 029-01

PHENTERMINE HYDROCHLORIDE CAPSULES, USP

37.5 mg

100 CAPSULES

Rx Only

KVK-TECH, INC.

caps 30s

Pack Size: 1000s

NDC 10702- 029-10

PHENTERMINE HYDROCHLORIDE CAPSULES, USP

37.5 mg

1000 CAPSULES

Rx Only

KVK-TECH, INC.

caps 30s

PRINCIPAL DISPLAY PANEL

Pack Size: 30s

NDC 10702- 025-03

PHENTERMINE  HYDROCHLORIDE  TABLETS, USP

37.5 mg

30 TABLETS

Rx Only

KVK-TECH, INC.

37.5 mg tablets 30s

Pack Size: 100s

NDC 10702- 025-01

PHENTERMINE HYDROCHLORIDE TABLETS, USP

37.5 mg

100 TABLETS

Rx Only

KVK-TECH, INC.

37.5 mg tablets 30s

Pack Size: 1000s

NDC 10702- 025-10

PHENTERMINE HYDROCHLORIDE TABLETS, USP

37.5 mg

1000 TABLETS

Rx Only

KVK-TECH, INC.

37.5 mg tablets 30s