nitrofurantoin

Generic: nitrofurantoin

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

Drug Facts

Product Profile

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

nitrofurantoin 25 mg/1, nitrofurantoin monohydrate 75 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8258
Product ID 68788-8258_1749c679-6cb0-4a4d-bdae-7e3406a46710
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208516
Listing Expiration 2026-12-31
Marketing Start 2022-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888258
Hyphenated Format 68788-8258

Supplemental Identifiers

RxCUI
1648755
UNII
927AH8112L E1QI2CQQ1I
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 nitrofurantoin (source: ndc)
Generic Name nitrofurantoin (source: ndc)
Application Number ANDA208516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (68788-8258-0)
  • 14 CAPSULE in 1 BOTTLE (68788-8258-1)
  • 28 CAPSULE in 1 BOTTLE (68788-8258-8)
source: ndc

Packages (3)

68788-8258-0 10 CAPSULE in 1 BOTTLE (68788-8258-0) 68788-8258-1 14 CAPSULE in 1 BOTTLE (68788-8258-1) 68788-8258-8 28 CAPSULE in 1 BOTTLE (68788-8258-8)

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 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": "1749c679-6cb0-4a4d-bdae-7e3406a46710", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["729f6bbb-ab64-4b65-979a-4ad7605c5947"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (68788-8258-0)", "package_ndc": "68788-8258-0", "marketing_start_date": "20220916"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (68788-8258-1)", "package_ndc": "68788-8258-1", "marketing_start_date": "20220916"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (68788-8258-8)", "package_ndc": "68788-8258-8", "marketing_start_date": "20230815"}], "brand_name": "Nitrofurantoin", "product_id": "68788-8258_1749c679-6cb0-4a4d-bdae-7e3406a46710", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "68788-8258", "generic_name": "Nitrofurantoin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA208516", "marketing_category": "ANDA", "marketing_start_date": "20220916", "listing_expiration_date": "20261231"}