nitrofurantoin (monohydrate/macrocrystals) (72162-1815)

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 72162-1815

Product ID 72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207372

Listing Expiration 2026-12-31

Marketing Start 2017-05-25

Pharmacologic Class

Established (EPC)

nitrofuran antibacterial [epc]

Chemical Structure

nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721621815

Hyphenated Format 72162-1815

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 ANDA207372 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
75 mg/1

source: ndc

Packaging

20 CAPSULE in 1 BOTTLE (72162-1815-2)
30 CAPSULE in 1 BOTTLE (72162-1815-3)
14 CAPSULE in 1 BOTTLE (72162-1815-4)
10 CAPSULE in 1 BOTTLE (72162-1815-8)
90 CAPSULE in 1 BOTTLE (72162-1815-9)

source: ndc

Packages (5)

72162-1815-2 20 CAPSULE in 1 BOTTLE (72162-1815-2) 72162-1815-3 30 CAPSULE in 1 BOTTLE (72162-1815-3) 72162-1815-4 14 CAPSULE in 1 BOTTLE (72162-1815-4) 72162-1815-8 10 CAPSULE in 1 BOTTLE (72162-1815-8) 72162-1815-9 90 CAPSULE in 1 BOTTLE (72162-1815-9)

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": "47b76c41-711d-4ff3-bfe4-314950e4b040", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["47b76c41-711d-4ff3-bfe4-314950e4b040"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (72162-1815-2)", "package_ndc": "72162-1815-2", "marketing_start_date": "20240403"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72162-1815-3)", "package_ndc": "72162-1815-3", "marketing_start_date": "20240403"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (72162-1815-4)", "package_ndc": "72162-1815-4", "marketing_start_date": "20240403"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (72162-1815-8)", "package_ndc": "72162-1815-8", "marketing_start_date": "20240403"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (72162-1815-9)", "package_ndc": "72162-1815-9", "marketing_start_date": "20240403"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "72162-1815", "generic_name": "Nitrofurantoin monohydrate/macrocrystals", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "brand_name_suffix": "(monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA207372", "marketing_category": "ANDA", "marketing_start_date": "20170525", "listing_expiration_date": "20261231"}