NDC 68784-108

Rectacort - HC

Hydrocortisone Acetate

Rectacort - HC is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Acino Products, Llc.. The primary component is Hydrocortisone Acetate.

Product ID68784-108_7b79a8c2-83a2-46ff-99bc-01b1c61bfd74
NDC68784-108
Product TypeHuman Prescription Drug
Proprietary NameRectacort - HC
Generic NameHydrocortisone Acetate
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2006-11-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAcino Products, LLC.
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength25 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68784-108-24

24 BLISTER PACK in 1 BOX (68784-108-24) > 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2006-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68784-108-12 [68784010812]

Rectacort - HC SUPPOSITORY
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-01
Inactivation Date2019-11-27

NDC 68784-108-24 [68784010824]

Rectacort - HC SUPPOSITORY
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-11-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE25 mg/1

OpenFDA Data

SPL SET ID:addb4490-6df1-4846-bd4b-5e987da15f23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1291082
  • 1429379
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Rectacort - HC" or generic name "Hydrocortisone Acetate"

    NDCBrand NameGeneric Name
    68784-108Rectacort - HCRectacort - HC
    0316-0140Ala ScalpHydrocortisone Acetate
    0713-0503ANUCORT-HCHydrocortisone Acetate
    43474-000bioCorneum HC Advanced Scar Supervision Anti-ItchHYDROCORTISONE ACETATE
    0037-6830Cortifoamhydrocortisone acetate
    16477-201Hemmorex-HChydrocortisone acetate
    16477-202Hemmorex-HChydrocortisone acetate
    0363-0972HydrocortisoneHydrocortisone Acetate
    11822-2069HydrocortisoneHydrocortisone Acetate
    0574-7090Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0574-7093Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0713-0493Hydrocortisone AcetateHYDROCORTISONE ACETATE
    10135-751Hydrocortisone AcetateHydrocortisone Acetate
    16571-676Hydrocortisone AcetateHydrocortisone Acetate
    24689-102Hydrocortisone AcetateHydrocortisone Acetate
    24689-103Hydrocortisone AcetateHydrocortisone Acetate
    39328-029Hydrocortisone AcetateHydrocortisone Acetate
    39328-129Hydrocortisone AcetateHydrocortisone Acetate
    42494-301Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-302Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-341Hydrocortisone AcetateHydrocortisone Acetate
    42494-342Hydrocortisone AcetateHydrocortisone Acetate
    47832-205Hydrocortisone AcetateHydrocortisone Acetate
    0179-8710KAISER PERMANENTEHydrocortisone acetate
    47682-923Medi-First 1% HydrocortisoneHydrocortisone acetate
    47682-207Medi-First Hydrocortisone 1%Hydrocortisone acetate
    15014-185NuCortHydrocortisone Acetate
    11509-5101Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHydrocortisone Acetate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.