NDC Code(s) : 55289-119-02, 55289-119-06
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ComproPROCHLORPERAZINE SUPPOSITORY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-119(NDC:0574-7226)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROCHLORPERAZINE(UNII: YHP6YLT61T)
(PROCHLORPERAZINE - UNII:YHP6YLT61T) 		PROCHLORPERAZINE25 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL PALMITATE(UNII: 6Y2XJ05B35)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROGENATED COCONUT OIL(UNII: JY81OXM1OM)
HYDROGENATED PALM KERNEL OIL(UNII: FM8D1RE2VP)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-119-022 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product22/12/2010
2NDC:55289-119-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product18/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040246 09/01/2000

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-119)

PRINCIPAL DISPLAY PANEL

Rx Only

Prochlorperazine Suppositories, USP

25 mg

FOR RECTAL USE ONLY

55289119 Label

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

55289119 Label