nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1748
Product ID 63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077066
Listing Expiration 2026-12-31
Marketing Start 2005-04-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636291748
Hyphenated Format 63629-1748

Supplemental Identifiers

RxCUI
1648755
UNII
927AH8112L E1QI2CQQ1I
NUI
N0000175494 M0014892

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/macrocrystals) (source: ndc)
Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Application Number ANDA077066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 6 CAPSULE in 1 BOTTLE (63629-1748-0)
  • 20 CAPSULE in 1 BOTTLE (63629-1748-1)
  • 14 CAPSULE in 1 BOTTLE (63629-1748-2)
  • 30 CAPSULE in 1 BOTTLE (63629-1748-3)
  • 28 CAPSULE in 1 BOTTLE (63629-1748-4)
  • 60 CAPSULE in 1 BOTTLE (63629-1748-5)
  • 10 CAPSULE in 1 BOTTLE (63629-1748-6)
  • 90 CAPSULE in 1 BOTTLE (63629-1748-7)
  • 21 CAPSULE in 1 BOTTLE (63629-1748-8)
  • 8 CAPSULE in 1 BOTTLE (63629-1748-9)
source: ndc

Packages (10)

63629-1748-0 6 CAPSULE in 1 BOTTLE (63629-1748-0) 63629-1748-1 20 CAPSULE in 1 BOTTLE (63629-1748-1) 63629-1748-2 14 CAPSULE in 1 BOTTLE (63629-1748-2) 63629-1748-3 30 CAPSULE in 1 BOTTLE (63629-1748-3) 63629-1748-4 28 CAPSULE in 1 BOTTLE (63629-1748-4) 63629-1748-5 60 CAPSULE in 1 BOTTLE (63629-1748-5) 63629-1748-6 10 CAPSULE in 1 BOTTLE (63629-1748-6) 63629-1748-7 90 CAPSULE in 1 BOTTLE (63629-1748-7) 63629-1748-8 21 CAPSULE in 1 BOTTLE (63629-1748-8) 63629-1748-9 8 CAPSULE in 1 BOTTLE (63629-1748-9)

Ingredients (2)

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

Linked Drug Pages (1)

Nitrofurantoin (monohydrate/macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b80e248-f12d-44f1-aa6d-c4548efda3d8", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["05f4b126-0fb9-5ee9-c89c-f229e60f84e3"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BOTTLE (63629-1748-0)", "package_ndc": "63629-1748-0", "marketing_start_date": "20200108"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (63629-1748-1)", "package_ndc": "63629-1748-1", "marketing_start_date": "20211221"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (63629-1748-2)", "package_ndc": "63629-1748-2", "marketing_start_date": "20071217"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63629-1748-3)", "package_ndc": "63629-1748-3", "marketing_start_date": "20081216"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (63629-1748-4)", "package_ndc": "63629-1748-4", "marketing_start_date": "20100713"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63629-1748-5)", "package_ndc": "63629-1748-5", "marketing_start_date": "20211221"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (63629-1748-6)", "package_ndc": "63629-1748-6", "marketing_start_date": "20150121"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63629-1748-7)", "package_ndc": "63629-1748-7", "marketing_start_date": "20150519"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (63629-1748-8)", "package_ndc": "63629-1748-8", "marketing_start_date": "20211221"}, {"sample": false, "description": "8 CAPSULE in 1 BOTTLE (63629-1748-9)", "package_ndc": "63629-1748-9", "marketing_start_date": "20211221"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "63629-1748", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin (monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA077066", "marketing_category": "ANDA", "marketing_start_date": "20050406", "listing_expiration_date": "20261231"}