nitrofurantoin (monohydrate/macrocrystals) (59746-762)

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)

Generic Name nitrofurantoin (monohydrate/macrocrystals)

Labeler jubilant cadista pharmaceuticals inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Jubilant Cadista Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59746-762

Product ID 59746-762_2096b57d-b4dd-568f-e063-6294a90a830d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211013

Listing Expiration 2026-12-31

Marketing Start 2022-02-22

Pharmacologic Class

Established (EPC)

nitrofuran antibacterial [epc]

Chemical Structure

nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59746762

Hyphenated Format 59746-762

Supplemental Identifiers

RxCUI

1648755

UPC

0359746762018 0359746762360

UNII

927AH8112L E1QI2CQQ1I

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 (monohydrate/macrocrystals) (source: ndc)

Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)

Application Number ANDA211013 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
75 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (59746-762-01)
1000 CAPSULE in 1 BOTTLE (59746-762-36)

source: ndc

Packages (2)

59746-762-01 100 CAPSULE in 1 BOTTLE (59746-762-01) 59746-762-36 1000 CAPSULE in 1 BOTTLE (59746-762-36)

Ingredients (2)

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

Linked Drug Pages (2)

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

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2096b57d-b4dd-568f-e063-6294a90a830d", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0359746762018", "0359746762360"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["266824c7-7e9f-4c5f-b642-3bb7bf1c4fe6"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Jubilant Cadista Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59746-762-01)", "package_ndc": "59746-762-01", "marketing_start_date": "20220222"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (59746-762-36)", "package_ndc": "59746-762-36", "marketing_start_date": "20220222"}], "brand_name": "NITROFURANTOIN (monohydrate/macrocrystals)", "product_id": "59746-762_2096b57d-b4dd-568f-e063-6294a90a830d", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "59746-762", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Jubilant Cadista Pharmaceuticals 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": "ANDA211013", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20261231"}