nitrofurantion

Generic: nitrofurantion

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

Drug Facts

Product Profile

Brand Name nitrofurantion
Generic Name nitrofurantion
Labeler nucare pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2363
Product ID 68071-2363_4b353a66-abe4-a233-e063-6294a90a685d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201722
Listing Expiration 2027-12-31
Marketing Start 2016-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680712363
Hyphenated Format 68071-2363

Supplemental Identifiers

RxCUI
1648759
UPC
0368071236378
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 nitrofurantion (source: ndc)
Generic Name nitrofurantion (source: ndc)
Application Number ANDA201722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE (68071-2363-7)
  • 28 CAPSULE in 1 BOTTLE (68071-2363-8)
source: ndc

Packages (2)

68071-2363-7 14 CAPSULE in 1 BOTTLE (68071-2363-7) 68071-2363-8 28 CAPSULE in 1 BOTTLE (68071-2363-8)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

Nitrofurantion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b353a66-abe4-a233-e063-6294a90a685d", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0368071236378"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["bd46cc46-0efa-d5d9-e053-2995a90a18f1"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (68071-2363-7)", "package_ndc": "68071-2363-7", "marketing_start_date": "20210311"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (68071-2363-8)", "package_ndc": "68071-2363-8", "marketing_start_date": "20210311"}], "brand_name": "Nitrofurantion", "product_id": "68071-2363_4b353a66-abe4-a233-e063-6294a90a685d", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "68071-2363", "generic_name": "Nitrofurantion", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantion", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA201722", "marketing_category": "ANDA", "marketing_start_date": "20160415", "listing_expiration_date": "20271231"}