nitrofurantoin

Generic: nitrofurantoin (monohydrate/macrocrystals)

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin
Generic Name nitrofurantoin (monohydrate/macrocrystals)
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6664
Product ID 50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211013
Listing Expiration 2027-12-31
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 500906664
Hyphenated Format 50090-6664

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 (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 (50090-6664-0)
  • 10 CAPSULE in 1 BOTTLE (50090-6664-1)
  • 6 CAPSULE in 1 BOTTLE (50090-6664-2)
source: ndc

Packages (3)

50090-6664-0 14 CAPSULE in 1 BOTTLE (50090-6664-0) 50090-6664-1 10 CAPSULE in 1 BOTTLE (50090-6664-1) 50090-6664-2 6 CAPSULE in 1 BOTTLE (50090-6664-2)

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": "41c1cb5c-46d8-41d0-8996-89061fa5c058", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["b6c5bbb0-86db-4a76-a1eb-98573a0b0adc"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (50090-6664-0)", "package_ndc": "50090-6664-0", "marketing_start_date": "20230830"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (50090-6664-1)", "package_ndc": "50090-6664-1", "marketing_start_date": "20230830"}, {"sample": false, "description": "6 CAPSULE in 1 BOTTLE (50090-6664-2)", "package_ndc": "50090-6664-2", "marketing_start_date": "20230830"}], "brand_name": "NITROFURANTOIN", "product_id": "50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "50090-6664", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "A-S Medication Solutions", "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": "ANDA211013", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20271231"}