nitrofurantoin

Generic: nitrofurantoin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler rising pharma holdings, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/5mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-888
Product ID 16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA009175
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571888
Hyphenated Format 16571-888

Supplemental Identifiers

RxCUI
311989 422434
UNII
927AH8112L
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 (source: ndc)
Generic Name nitrofurantoin (source: ndc)
Application Number NDA009175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

16571-888-06 1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE

Ingredients (1)

nitrofurantoin (50 mg/5mL)

Linked Drug Pages (1)

Nitrofurantoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b6694787-d7b8-4bcb-8dff-5ff30a83443a", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989", "422434"], "spl_set_id": ["89095f4d-e142-465e-b378-da24f6eeaf2b"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (16571-888-06)  / 60 mL in 1 BOTTLE", "package_ndc": "16571-888-06", "marketing_start_date": "20240201"}], "brand_name": "Nitrofurantoin", "product_id": "16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "16571-888", "generic_name": "Nitrofurantoin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/5mL"}], "application_number": "NDA009175", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}