nitrofurantoin

Generic: nitrofurantoin

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

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin
Labeler alembic pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-390
Product ID 62332-390_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211935
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332390
Hyphenated Format 62332-390

Supplemental Identifiers

RxCUI
311994 311995 1648759
UPC
0362332390311 0362332389315 0362332391318
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 ANDA211935 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (62332-390-31)
  • 1000 CAPSULE in 1 BOTTLE (62332-390-91)
source: ndc

Packages (2)

62332-390-31 100 CAPSULE in 1 BOTTLE (62332-390-31) 62332-390-91 1000 CAPSULE in 1 BOTTLE (62332-390-91)

Ingredients (1)

nitrofurantoin (50 mg/1)

Linked Drug Pages (1)

NITROFURANTOIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b5516b0-5fe8-45f0-a7f9-3bf05081e74f", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0362332390311", "0362332389315", "0362332391318"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["a8a0d7d7-1e18-46a7-a1f8-e97499820035"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62332-390-31)", "package_ndc": "62332-390-31", "marketing_start_date": "20210701"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (62332-390-91)", "package_ndc": "62332-390-91", "marketing_start_date": "20210701"}], "brand_name": "NITROFURANTOIN", "product_id": "62332-390_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "62332-390", "generic_name": "NITROFURANTOIN", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROFURANTOIN", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA211935", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}