NDC 51862-159

HYDROCORTISONE BUTYRATE

Hydrocortisone Butyrate

HYDROCORTISONE BUTYRATE is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Hydrocortisone Butyrate.

Product ID51862-159_5cc0fa38-756a-4fe1-9e2e-789273ed8014
NDC51862-159
Product TypeHuman Prescription Drug
Proprietary NameHYDROCORTISONE BUTYRATE
Generic NameHydrocortisone Butyrate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2019-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA209556
Labeler NameMayne Pharma Inc.
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51862-159-04

1 BOTTLE in 1 CARTON (51862-159-04) > 118 mL in 1 BOTTLE
Marketing Start Date2019-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-159-04 [51862015904]

HYDROCORTISONE BUTYRATE LOTION
Marketing CategoryANDA
Application NumberANDA209556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-29

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE BUTYRATE1 mg/mL

Pharmacological Class

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

NDC Crossover Matching brand name "HYDROCORTISONE BUTYRATE" or generic name "Hydrocortisone Butyrate"

NDCBrand NameGeneric Name
0472-0490Hydrocortisone ButyrateHydrocortisone Butyrate
21695-971Hydrocortisone ButyrateHydrocortisone Butyrate
51672-4061Hydrocortisone ButyrateHydrocortisone Butyrate
51672-4074Hydrocortisone ButyrateHydrocortisone Butyrate
51672-4083Hydrocortisone ButyrateHydrocortisone Butyrate
51862-159HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
52565-087Hydrocortisone ButyrateHYDROCORTISONE BUTYRATE
68180-951Hydrocortisone ButyrateHydrocortisone Butyrate
68462-464Hydrocortisone ButyrateHydrocortisone Butyrate
68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
68682-271Hydrocortisone Butyratehydrocortisone butyrate
68682-273Hydrocortisone Butyratehydrocortisone butyrate
68682-384Hydrocortisone ButyrateHYDROCORTISONE BUTYRATE
68682-392HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
68788-7719Hydrocortisone ButyrateHydrocortisone Butyrate Lotion
70512-032Hydrocortisone ButyrateHydrocortisone Butyrate
16781-382LocoidHYDROCORTISONE BUTYRATE
16781-391LocoidHYDROCORTISONE BUTYRATE
16781-392LocoidHYDROCORTISONE BUTYRATE
16781-384Locoid LipocreamHYDROCORTISONE BUTYRATE

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