NDC 69315-312

Procto-Med HC

Hydrocortisone

Procto-Med HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Hydrocortisone.

Product ID69315-312_06996b2b-8e00-4739-aa98-6d4774ce2dfb
NDC69315-312
Product TypeHuman Prescription Drug
Proprietary NameProcto-Med HC
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2020-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA085025
Labeler NameLeading Pharma, LLC
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69315-312-28

1 TUBE in 1 CARTON (69315-312-28) > 28 g in 1 TUBE
Marketing Start Date2020-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69315-312-28 [69315031228]

Procto-Med HC CREAM
Marketing CategoryANDA
Application NumberANDA085025
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2020-02-14

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

Pharmacological Class

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

NDC Crossover Matching brand name "Procto-Med HC" or generic name "Hydrocortisone"

NDCBrand NameGeneric Name
68071-3333Procto-Med HCProcto-Med HC
69315-302Procto-Med HCProcto-Med HC
50090-2931Procto-Med HCProcto-Med HC
69315-312Procto-Med HCProcto-Med HC
68071-2261Procto-Med HCProcto-Med HC
0096-0732Aquanil HCHydrocortisone
0113-0793basic care hydrocortisonehydrocortisone
0113-7369basic care hydrocortisoneHydrocortisone
0113-7006Basic Case Hydrocortisone Anti-Itchhydrocortisone
0009-0012CORTEFhydrocortisone
0009-0031CORTEFhydrocortisone
0009-0044CORTEFhydrocortisone
0113-0471Good Sense Anti Itchhydrocortisone
0113-0541good sense anti itchHydrocortisone
0113-0973Good Sense Anti Itchhydrocortisone
0113-1369good sense anti itchHydrocortisone
0115-1696HYDROCORTISONEhydrocortisone
0115-1697HYDROCORTISONEhydrocortisone
0115-1700HYDROCORTISONEhydrocortisone
0143-1252HydrocortisoneHydrocortisone
0143-1253HydrocortisoneHydrocortisone
0143-1254HydrocortisoneHydrocortisone
0168-0014HYDROCORTISONEHYDROCORTISONE
0168-0015hydrocortisoneHydrocortisone
0168-0016HYDROCORTISONEHYDROCORTISONE
0168-0020HydrocortisoneHydrocortisone
0168-0080HydrocortisoneHydrocortisone
0168-0146HydrocortisoneHydrocortisone
0168-0154HYDROCORTISONEHYDROCORTISONE
0168-0181HYDROCORTISONEHYDROCORTISONE
0168-0288Hydrocortisonehydrocortisone
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