NDC Code(s) : 72835-802-02
Packager : V2 Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DuloxicaineDuloxetine and Lidocaine KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-802
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
ALLANTOIN(UNII: 344S277G0Z)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
ASTAXANTHIN(UNII: 8XPW32PR7I)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BERGAMOT OIL(UNII: 39W1PKE3JI)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 132584PQMO)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CYCLOMETHICONE(UNII: NMQ347994Z)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIMETHICONE 200(UNII: RGS4T2AS00)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
EDETATE SODIUM(UNII: MP1J8420LU)
EMU OIL(UNII: 344821WD61)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
INDIAN FRANKINCENSE(UNII: 4PW41QCO2M)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
LAURETH-7(UNII: Z95S6G8201)
LEVOMENOL(UNII: 24WE03BX2T)
N-ACETYL-GLUCOSAMINE THIAZOLINE(UNII: ML5FHL557A)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
POLYQUATERNIUM-10 (400 MPA.S AT 2%)(UNII: HB1401PQFS)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SALICYLIC ACID(UNII: O414PZ4LPZ)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
STEARIC ACID(UNII: 4ELV7Z65AP)
TEA TREE OIL(UNII: VIF565UC2G)
TOCOPHEROL(UNII: R0ZB2556P8)
TROLAMINE(UNII: 9O3K93S3TK)
TURMERIC OIL(UNII: 6KGS8SP16U)
VACCINIUM MYRTILLUS ANTHOCYANOSIDES(UNII: R911H793SU)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72835-802-021 in 1 CARTON 23/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/23/2023

LABELER - V2 Pharma, LLC(102457346)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 manufacture(68180-295), pack(68180-295)

Establishment
Name Address ID/FEI Business Operations
AEC Consumer Products, LLC 080994102 pack(86089-200)

Establishment
Name Address ID/FEI Business Operations
V2 Pharma, LLC 102457346 label(72835-802)

PRINCIPAL DISPLAY PANEL

The packaging for Duloxicaine is shown below

Duloxicaine Packaging

Duloxicaine Packaging