Phenazopyridine hydrochloride tablet, film coated

Ingredients and appearance - Product information

Phenazopyridine hydrochloride tablet, film coated- Phenazopyridine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68071-4575
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Phenazopyridine hydrochloride ( UNII: 0EWG668W17)( Phenazopyridine - UNII: K2J09EMJ52 ) 200 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone k30 ( UNII: U725QWY32X)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Magnesium stearate ( UNII: 70097M6I30)
Croscarmellose sodium ( UNII: M28OL1HH48)

Product Characteristics

Size 10 mm Color brown (Reddish-Brown)
Imprint Code 813 Score
Shape ROUND

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68071-4575-1 10 in 1 BOTTLE 2018/09/26
2 NDC: 68071-4575-5 15 in 1 BOTTLE 2018/09/26
3 NDC: 68071-4575-6 60 in 1 BOTTLE 2018/09/26

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA 2018/09/26

Labeler - NuCare Pharmaceuticals,Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack( 68071-4575)