nitrofurantoin (macrocrystals)

Generic: nitrofurantoin (macrocrystals)

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin (macrocrystals)
Generic Name nitrofurantoin (macrocrystals)
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-795
Product ID 59651-795_04053ba5-ceb5-4f34-9878-8abf1e552da2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077025
Listing Expiration 2026-12-31
Marketing Start 2023-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651795
Hyphenated Format 59651-795

Supplemental Identifiers

RxCUI
311994 1648759
UNII
927AH8112L
NUI
N0000175494 M0014892

Packaging Origin

Original Packager
true

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 (macrocrystals) (source: ndc)
Generic Name nitrofurantoin (macrocrystals) (source: ndc)
Application Number ANDA077025 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-795-01)
source: ndc

Packages (1)

59651-795-01 100 CAPSULE in 1 BOTTLE (59651-795-01)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

nitrofurantoin (macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "04053ba5-ceb5-4f34-9878-8abf1e552da2", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311994", "1648759"], "spl_set_id": ["b2fc8354-b413-4c9d-88ec-ccc43d059d51"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-795-01)", "package_ndc": "59651-795-01", "marketing_start_date": "20230517"}], "brand_name": "nitrofurantoin (macrocrystals)", "product_id": "59651-795_04053ba5-ceb5-4f34-9878-8abf1e552da2", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "59651-795", "generic_name": "nitrofurantoin (macrocrystals)", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin (macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA077025", "marketing_category": "ANDA", "marketing_start_date": "20230517", "listing_expiration_date": "20261231"}