nitrofurantoin monohydrate/ macrocrystalline

Generic: nitrofurantoin monohydrate/macrocrystalline

Labeler: alvogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin monohydrate/ macrocrystalline
Generic Name nitrofurantoin monohydrate/macrocrystalline
Labeler alvogen inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-303
Product ID 47781-303_c60467a9-d071-afab-5df9-a6642c176b09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020064
Listing Expiration 2026-12-31
Marketing Start 2011-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781303
Hyphenated Format 47781-303

Supplemental Identifiers

RxCUI
1648755
UPC
0347781303013
UNII
927AH8112L E1QI2CQQ1I
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 monohydrate/ macrocrystalline (source: ndc)
Generic Name nitrofurantoin monohydrate/macrocrystalline (source: ndc)
Application Number NDA020064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (47781-303-01)
source: ndc

Packages (1)

47781-303-01 100 CAPSULE in 1 BOTTLE (47781-303-01)

Ingredients (2)

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

Linked Drug Pages (1)

Nitrofurantoin Monohydrate/ Macrocrystalline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c60467a9-d071-afab-5df9-a6642c176b09", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0347781303013"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["1a86deef-0887-43b1-bb96-dbc222b15931"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (47781-303-01)", "package_ndc": "47781-303-01", "marketing_start_date": "20110525"}], "brand_name": "Nitrofurantoin Monohydrate/ Macrocrystalline", "product_id": "47781-303_c60467a9-d071-afab-5df9-a6642c176b09", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "47781-303", "generic_name": "Nitrofurantoin Monohydrate/Macrocrystalline", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Monohydrate/ Macrocrystalline", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "NDA020064", "marketing_category": "NDA", "marketing_start_date": "20110525", "listing_expiration_date": "20261231"}