NDC 50436-0250-7
API & Excipient Details

Phentermine Hydrochloride marketed by Unit Dose Services under NDC Code 50436-0250-7

NDC Code(s) : 50436-0250-1, 50436-0250-2, 50436-0250-3, 50436-0250-4, 50436-0250-5, 50436-0250-6, 50436-0250-7
Packager : Unit Dose Services

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:50436-0250(NDC:10702-025)
Route of Administration	ORAL	DEA Schedule	CIV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)	PHENTERMINE HYDROCHLORIDE	37.5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)

Product Characteristics
Color	WHITE, BLUE (SPECKLES)	Score	2 pieces
Shape	OVAL	Size	10 mm
Flavor		Imprint Code	K;25
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50436-0250-1	7 in 1 BOTTLE Type 0: Not a Combination Product	07/07/2017
2	NDC:50436-0250-2	14 in 1 BOTTLE Type 0: Not a Combination Product	07/07/2017
3	NDC:50436-0250-3	21 in 1 BOTTLE Type 0: Not a Combination Product	07/07/2017
4	NDC:50436-0250-4	28 in 1 BOTTLE Type 0: Not a Combination Product	07/07/2017
5	NDC:50436-0250-5	30 in 1 BOTTLE Type 0: Not a Combination Product	17/03/2021
6	NDC:50436-0250-6	60 in 1 BOTTLE Type 0: Not a Combination Product	17/03/2021
7	NDC:50436-0250-7	56 in 1 BOTTLE Type 0: Not a Combination Product	04/04/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040876	08/15/2012

LABELER - Unit Dose Services(831995316)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Services		831995316	REPACK(50436-0250), RELABEL(50436-0250)

PRINCIPAL DISPLAY PANEL

7 TAB

7 TAB

7 TAB

7 TAB

7 TAB