nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/1, nitrofurantoin monohydrate 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-546
Product ID 71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077066
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

Pharmacologic Class

Established (EPC)
nitrofuran antibacterial [epc]
Chemical Structure
nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205546
Hyphenated Format 71205-546

Supplemental Identifiers

RxCUI
1648755
UPC
0371205546106
UNII
927AH8112L E1QI2CQQ1I
NUI
N0000175494 M0014892

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Application Number ANDA077066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (71205-546-10)
  • 14 CAPSULE in 1 BOTTLE (71205-546-14)
  • 20 CAPSULE in 1 BOTTLE (71205-546-20)
  • 30 CAPSULE in 1 BOTTLE (71205-546-30)
  • 60 CAPSULE in 1 BOTTLE (71205-546-60)
  • 90 CAPSULE in 1 BOTTLE (71205-546-90)
source: ndc

Packages (6)

71205-546-10 10 CAPSULE in 1 BOTTLE (71205-546-10) 71205-546-14 14 CAPSULE in 1 BOTTLE (71205-546-14) 71205-546-20 20 CAPSULE in 1 BOTTLE (71205-546-20) 71205-546-30 30 CAPSULE in 1 BOTTLE (71205-546-30) 71205-546-60 60 CAPSULE in 1 BOTTLE (71205-546-60) 71205-546-90 90 CAPSULE in 1 BOTTLE (71205-546-90)

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 mg/1)

Linked Drug Pages (1)

Nitrofurantoin (monohydrate/macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0371205546106"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["98c50178-3150-42a5-84f0-65b373f4978f"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71205-546-10)", "package_ndc": "71205-546-10", "marketing_start_date": "20210323"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (71205-546-14)", "package_ndc": "71205-546-14", "marketing_start_date": "20210323"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71205-546-20)", "package_ndc": "71205-546-20", "marketing_start_date": "20210323"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71205-546-30)", "package_ndc": "71205-546-30", "marketing_start_date": "20210323"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71205-546-60)", "package_ndc": "71205-546-60", "marketing_start_date": "20210323"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71205-546-90)", "package_ndc": "71205-546-90", "marketing_start_date": "20210323"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "71205-546", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin (monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA077066", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}