Hydrocortisone tablet

References

  1. Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases.Philadelphia: WB Saunders Company 1992:1050-1.
  2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis1989:11(6):954-63.

Ingredients and appearance - Product information

Hydrocortisone tablet- Hydrocortisone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-789
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color white Size 8 mm
Shape ROUND Score 2
Imprint Code 3578;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040761 USA

Hydrocortisone tablet- Hydrocortisone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-469
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color white Size 9 mm
Shape ROUND Score 2
Imprint Code 3579;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040761 USA

Hydrocortisone tablet- Hydrocortisone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-930
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 20 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color white Size 10 mm
Shape ROUND Score 2
Imprint Code 3580;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040761 USA

Labeler - American Health Packaging( 929561009)

Establishment

Name ID/FEI Business Operations
American Health Packaging 929561009 repack( 68084-789, 68084-469, 68084-930)

Package/label display panel blister 10 mg

HYDROCORTISONE
TABLET, USP

10 mg