NDC Code(s) : 61786-040-07
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rectacort - HCHYDROCORTISONE ACETATE SUPPOSITORY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-040(NDC:68784-108)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE(UNII: 3X7931PO74)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE ACETATE25 mg
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED COCO-GLYCERIDES(UNII: XDD37N2GPR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-040-0712 in 1 BOX Type 0: Not a Combination Product06/04/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/06/2017

PRINCIPAL DISPLAY PANEL

DRUG: Rectacort - HC

GENERIC: HYDROCORTISONE ACETATE

DOSAGE: SUPPOSITORY

ADMINSTRATION: RECTAL

NDC: 61786-040-07

PACKAGING: 12 in 1 BOX

ACTIVE INGREDIENT(S):

  • HYDROCORTISONE ACETATE 25mg in 1

INACTIVE INGREDIENT(S):

  • HYDROGENATED COCO-GLYCERIDES

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