nitrofurantoin mono

Generic: nitrofurantoin monohydrate

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin mono
Generic Name nitrofurantoin monohydrate
Labeler pharmpak, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-849
Product ID 54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020064
Listing Expiration 2026-12-31
Marketing Start 2019-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348849
Hyphenated Format 54348-849

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 mono (source: ndc)
Generic Name nitrofurantoin monohydrate (source: ndc)
Application Number NDA020064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-849-06) / 6 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-849-10) / 10 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-849-14) / 14 CAPSULE in 1 BOTTLE
source: ndc

Packages (3)

54348-849-06 1 BOTTLE in 1 BOX (54348-849-06) / 6 CAPSULE in 1 BOTTLE 54348-849-10 1 BOTTLE in 1 BOX (54348-849-10) / 10 CAPSULE in 1 BOTTLE 54348-849-14 1 BOTTLE in 1 BOX (54348-849-14) / 14 CAPSULE in 1 BOTTLE

Ingredients (2)

nitrofurantoin (25 mg/1) nitrofurantoin monohydrate (75 mg/1)

Linked Drug Pages (1)

Nitrofurantoin Mono ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eaa5e1eb-d68d-a3f7-e053-2995a90aa735", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["d9840719-271f-42a9-a5c9-3e039ec8fbac"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-849-06)  / 6 CAPSULE in 1 BOTTLE", "package_ndc": "54348-849-06", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-849-10)  / 10 CAPSULE in 1 BOTTLE", "package_ndc": "54348-849-10", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-849-14)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "54348-849-14", "marketing_start_date": "20190710"}], "brand_name": "Nitrofurantoin Mono", "product_id": "54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "54348-849", "generic_name": "NITROFURANTOIN MONOHYDRATE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Mono", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "NDA020064", "marketing_category": "NDA", "marketing_start_date": "20190710", "listing_expiration_date": "20261231"}