Nitrofurantoin capsule

Pregnancy

Teratogenic Effects


Pregnancy Category B


Non-Teratogenic Effects
Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The relationship of this finding to potential human carcinogenesis is presently unknown. Because of the uncertainty regarding the human implications of these animal data, this drug should be used during pregnancy only if clearly needed.

Ingredients and appearance - Product information

Nitrofurantoin capsule- Nitrofurantoin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-040
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nitrofurantoin ( UNII: 927AH8112L)( Nitrofurantoin - UNII: 927AH8112L ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Ferrosoferric oxide ( UNII: XM0M87F357)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Aluminum oxide ( UNII: LMI26O6933)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Gelatin ( UNII: 2G86QN327L)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink Score 1
Shape CAPSULE (CAPSULE) Imprint Code 2131;Z;100mg
Size 16 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-040-04 14 in 1 BLISTER PACK 2011/11/10

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA073652 USA 2011/11/10

Labeler - REMEDYREPACK INC.( 829572556)