NDC Code(s) : 68180-947-02, 68180-947-01
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Betamethasone dipropionateBetamethasone dipropionate OINTMENT, AUGMENTED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-947
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE DIPROPIONATE(UNII: 826Y60901U)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM(UNII: 4T6H12BN9U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLENE GLYCOL MONOPALMITOSTEARATE(UNII: F76354LMGR)
WHITE WAX(UNII: 7G1J5DA97F)
Product Characteristics
Color WHITE (white to off-white opaque) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-947-021 in 1 CARTON 19/03/2020
150 g in 1 TUBE Type 0: Not a Combination Product
2NDC:68180-947-011 in 1 CARTON 19/03/2020
215 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209106 03/19/2020

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 650595213 MANUFACTURE(68180-947), PACK(68180-947)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 g Carton

NDC 68180-947-02

Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%

(*Strength expressed as betamethasone)

For topical use only

Not for oral, ophthalmic, or intravaginal use

Rx only

Keep out of reach of children.

NET WT 50 g

50g-carton

PRINCIPAL DISPLAY PANEL - 50 g Container (tube) label

NDC 68180-947-02

Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%

(*Strength expressed as betamethasone)

For topical use only

Not for oral, ophthalmic, or intravaginal use

Rx only

Keep out of reach of children.

NET WT 50 g

50g-carton