nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

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

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler alvogen inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-307
Product ID 47781-307_97785cf3-ab56-4697-3ab6-7451919d889a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016620
Listing Expiration 2026-12-31
Marketing Start 2010-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781307
Hyphenated Format 47781-307

Supplemental Identifiers

RxCUI
311994 311995 1648759
UPC
0347781307011 0347781306014 0347781308018
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 NDA016620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (47781-307-01)
source: ndc

Packages (1)

47781-307-01 100 CAPSULE in 1 BOTTLE, PLASTIC (47781-307-01)

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": "97785cf3-ab56-4697-3ab6-7451919d889a", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0347781307011", "0347781306014", "0347781308018"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["62c1bb9c-79a2-41e3-9dfa-352f92253881"], "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, PLASTIC (47781-307-01)", "package_ndc": "47781-307-01", "marketing_start_date": "20100927"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "47781-307_97785cf3-ab56-4697-3ab6-7451919d889a", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "47781-307", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "NDA016620", "marketing_category": "NDA", "marketing_start_date": "20100927", "listing_expiration_date": "20261231"}