nitrofurantoin (monohydrate/macrocrystals) (70518-4026)

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)

Generic Name nitrofurantoin (monohydrate/macrocrystals)

Labeler remedyrepack inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4026

Product ID 70518-4026_3f913de8-bfb7-9929-e063-6294a90abbc6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA217357

Listing Expiration 2026-12-31

Marketing Start 2024-02-21

Pharmacologic Class

Established (EPC)

nitrofuran antibacterial [epc]

Chemical Structure

nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184026

Hyphenated Format 70518-4026

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 ANDA217357 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
75 mg/1

source: ndc

Packaging

10 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-0)
14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-1)
30 CAPSULE in 1 BLISTER PACK (70518-4026-2)
20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-3)

source: ndc

Packages (4)

70518-4026-0 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-0) 70518-4026-1 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-1) 70518-4026-2 30 CAPSULE in 1 BLISTER PACK (70518-4026-2) 70518-4026-3 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-3)

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": "3f913de8-bfb7-9929-e063-6294a90abbc6", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["e55f3dc2-c754-4550-a2c0-c304471a8791"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-0)", "package_ndc": "70518-4026-0", "marketing_start_date": "20240221"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-1)", "package_ndc": "70518-4026-1", "marketing_start_date": "20240221"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4026-2)", "package_ndc": "70518-4026-2", "marketing_start_date": "20240503"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-3)", "package_ndc": "70518-4026-3", "marketing_start_date": "20250326"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "70518-4026_3f913de8-bfb7-9929-e063-6294a90abbc6", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "70518-4026", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "REMEDYREPACK INC.", "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": "ANDA217357", "marketing_category": "ANDA", "marketing_start_date": "20240221", "listing_expiration_date": "20261231"}