nitrofurantoin

Generic: nitrofurantoin

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

Drug Facts

Product Profile

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

nitrofurantoin 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-391
Product ID 46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47
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 46708391
Hyphenated Format 46708-391

Supplemental Identifiers

RxCUI
311994 311995 1648759
UPC
0346708389314 0346708391317 0346708390310
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
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (46708-391-31)
  • 1000 CAPSULE in 1 BOTTLE (46708-391-91)
source: ndc

Packages (2)

46708-391-31 100 CAPSULE in 1 BOTTLE (46708-391-31) 46708-391-91 1000 CAPSULE in 1 BOTTLE (46708-391-91)

Ingredients (1)

nitrofurantoin (100 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": "dacd91fc-bf3f-4ff3-a2ae-c0210796af47", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0346708389314", "0346708391317", "0346708390310"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["152e4fe2-7665-4725-af76-b241bd816937"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-391-31)", "package_ndc": "46708-391-31", "marketing_start_date": "20210701"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-391-91)", "package_ndc": "46708-391-91", "marketing_start_date": "20210701"}], "brand_name": "NITROFURANTOIN", "product_id": "46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "46708-391", "generic_name": "NITROFURANTOIN", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROFURANTOIN", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA211935", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}