nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1643
Product ID 0115-1643_fa122415-d787-4019-85f0-3602f1892e8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073671
Listing Expiration 2026-12-31
Marketing Start 2007-03-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151643
Hyphenated Format 0115-1643

Supplemental Identifiers

RxCUI
311995 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 ANDA073671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0115-1643-01)
  • 1000 CAPSULE in 1 BOTTLE (0115-1643-03)
source: ndc

Packages (2)

0115-1643-01 100 CAPSULE in 1 BOTTLE (0115-1643-01) 0115-1643-03 1000 CAPSULE in 1 BOTTLE (0115-1643-03)

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": "fa122415-d787-4019-85f0-3602f1892e8d", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311995", "1648759"], "spl_set_id": ["341c75ac-fba5-480d-a221-868c4195cb6f"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0115-1643-01)", "package_ndc": "0115-1643-01", "marketing_start_date": "20070308"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0115-1643-03)", "package_ndc": "0115-1643-03", "marketing_start_date": "20070308"}], "brand_name": "Nitrofurantoin Macrocrystals", "product_id": "0115-1643_fa122415-d787-4019-85f0-3602f1892e8d", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "0115-1643", "generic_name": "Nitrofurantoin Macrocrystals", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA073671", "marketing_category": "ANDA", "marketing_start_date": "20070308", "listing_expiration_date": "20261231"}