nitrofurantoin

Generic: nitrofurantoin

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitrofurantoin 25 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-496
Product ID 70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216385
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954496
Hyphenated Format 70954-496

Supplemental Identifiers

RxCUI
311989
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 ANDA216385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 230 mL in 1 BOTTLE (70954-496-10)
source: ndc

Packages (1)

70954-496-10 230 mL in 1 BOTTLE (70954-496-10)

Ingredients (1)

nitrofurantoin (25 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": "7e94d701-0d57-4a04-bc74-d07febb8ad7b", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311989"], "spl_set_id": ["3b377aff-2d4b-43ea-84c9-8e72c1421b7b"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "230 mL in 1 BOTTLE (70954-496-10)", "package_ndc": "70954-496-10", "marketing_start_date": "20230417"}], "brand_name": "Nitrofurantoin", "product_id": "70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b", "dosage_form": "SUSPENSION", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70954-496", "generic_name": "Nitrofurantoin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/5mL"}], "application_number": "ANDA216385", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}