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 50 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-753
Product ID 59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074967
Listing Expiration 2026-12-31
Marketing Start 2023-05-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651753
Hyphenated Format 59651-753

Supplemental Identifiers

RxCUI
311995
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 ANDA074967 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-753-01)
source: ndc

Packages (1)

59651-753-01 100 CAPSULE in 1 BOTTLE (59651-753-01)

Ingredients (1)

nitrofurantoin (50 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": "bac7a3bd-df62-4b82-853c-f4d6ea650c62", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311995"], "spl_set_id": ["158e08ff-9b6d-4d60-a218-74dc289cf023"], "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 (59651-753-01)", "package_ndc": "59651-753-01", "marketing_start_date": "20230512"}], "brand_name": "nitrofurantoin (macrocrystals)", "product_id": "59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "59651-753", "generic_name": "nitrofurantoin (macrocrystals)", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin (macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA074967", "marketing_category": "ANDA", "marketing_start_date": "20230512", "listing_expiration_date": "20261231"}