nitrofurantoin oral suspension (0121-1996)

Drug Facts

Product Profile

Brand Name nitrofurantoin oral suspension

Generic Name nitrofurantoin oral suspension

Labeler pai holdings, llc dba pai pharma

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer

PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1996

Product ID 0121-1996_6a8f5c1d-c799-4ade-935b-101d5c0de477

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201355

Marketing Start 2024-06-10

Marketing End 2026-04-30

Pharmacologic Class

Established (EPC)

nitrofuran antibacterial [epc]

Chemical Structure

nitrofurans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211996

Hyphenated Format 0121-1996

Supplemental Identifiers

RxCUI

311989

UNII

927AH8112L

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 oral suspension (source: ndc)

Generic Name nitrofurantoin oral suspension (source: ndc)

Application Number ANDA201355 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/5mL

source: ndc

Packaging

10 CUP, UNIT-DOSE in 1 CASE (0121-1996-95) / 10 mL in 1 CUP, UNIT-DOSE (0121-1996-10)

source: ndc

Packages (1)

0121-1996-95 10 CUP, UNIT-DOSE in 1 CASE (0121-1996-95) / 10 mL in 1 CUP, UNIT-DOSE (0121-1996-10)

Ingredients (1)

nitrofurantoin (25 mg/5mL)

Linked Drug Pages (1)

Nitrofurantoin Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "6a8f5c1d-c799-4ade-935b-101d5c0de477", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["6e647179-c075-43ca-85f7-7d17940ed84b"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CASE (0121-1996-95)  / 10 mL in 1 CUP, UNIT-DOSE (0121-1996-10)", "package_ndc": "0121-1996-95", "marketing_end_date": "20260430", "marketing_start_date": "20240610"}], "brand_name": "Nitrofurantoin Oral Suspension", "product_id": "0121-1996_6a8f5c1d-c799-4ade-935b-101d5c0de477", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "0121-1996", "generic_name": "Nitrofurantoin Oral Suspension", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Oral Suspension", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/5mL"}], "application_number": "ANDA201355", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20240610"}