nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

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

Drug Facts

Product Profile

Brand Name nitrofurantoin (monohydrate/macrocrystals)
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler qpharma, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
QPharma, Inc.

Identifiers & Regulatory

Product NDC 42708-184
Product ID 42708-184_4586f98c-081a-3d32-e063-6394a90aeb5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211013
Listing Expiration 2026-12-31
Marketing Start 2022-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42708184
Hyphenated Format 42708-184

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 (monohydrate/macrocrystals) (source: ndc)
Generic Name nitrofurantoin (monohydrate/macrocrystals) (source: ndc)
Application Number ANDA211013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-14)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-28)
source: ndc

Packages (2)

42708-184-14 14 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-14) 42708-184-28 28 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-28)

Ingredients (2)

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

Linked Drug Pages (1)

NITROFURANTOIN (monohydrate/macrocrystals) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4586f98c-081a-3d32-e063-6394a90aeb5a", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["055477be-e42c-fe8b-e063-6394a90a0449"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["QPharma, Inc."]}, "finished": true, "packaging": [{"sample": true, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-14)", "package_ndc": "42708-184-14", "marketing_start_date": "20251017"}, {"sample": true, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-28)", "package_ndc": "42708-184-28", "marketing_start_date": "20230922"}], "brand_name": "NITROFURANTOIN (monohydrate/macrocrystals)", "product_id": "42708-184_4586f98c-081a-3d32-e063-6394a90aeb5a", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "42708-184", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "QPharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROFURANTOIN (monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA211013", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20261231"}