NDC 72934-2113

HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%

Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2%

HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2% is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Hydrocortisone; Levocetirizine Dihydrochloride.

Product ID72934-2113_88df0f6a-620d-6a38-e053-2a95a90a3a8d
NDC72934-2113
Product TypeHuman Prescription Drug
Proprietary NameHYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%
Generic NameHydrocortisone 2.5% / Levocetirizine Dihydrochloride 2%
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-05-15
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSincerus Florida, LLC
Substance NameHYDROCORTISONE; LEVOCETIRIZINE DIHYDROCHLORIDE
Active Ingredient Strength3 g/100g; g/100g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72934-2113-2

30 g in 1 BOTTLE, PUMP (72934-2113-2)
Marketing Start Date2019-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72934-2113-2 [72934211302]

HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2% CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-15

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE2.5 g/100g

OpenFDA Data

SPL SET ID:88df0f6a-620c-6a38-e053-2a95a90a3a8d
Manufacturer
UNII

Pharmacological Class

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]
  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]
  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]
  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

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