nitrofurantoin (monohydrate/macrocrystals)

Generic: nitrofurantoin (monohydrate/macrocrystals)

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

Drug Facts

Product Profile

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

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-884
Product ID 76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b
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 76420884
Hyphenated Format 76420-884

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
  • 1000 CAPSULE in 1 BOTTLE (76420-884-00)
  • 100 CAPSULE in 1 BOTTLE (76420-884-01)
  • 7 CAPSULE in 1 BOTTLE (76420-884-07)
  • 10 CAPSULE in 1 BOTTLE (76420-884-10)
  • 12 CAPSULE in 1 BOTTLE (76420-884-12)
  • 14 CAPSULE in 1 BOTTLE (76420-884-14)
  • 20 CAPSULE in 1 BOTTLE (76420-884-20)
  • 28 CAPSULE in 1 BOTTLE (76420-884-28)
  • 30 CAPSULE in 1 BOTTLE (76420-884-30)
  • 60 CAPSULE in 1 BOTTLE (76420-884-60)
  • 90 CAPSULE in 1 BOTTLE (76420-884-90)
source: ndc

Packages (11)

76420-884-00 1000 CAPSULE in 1 BOTTLE (76420-884-00) 76420-884-01 100 CAPSULE in 1 BOTTLE (76420-884-01) 76420-884-07 7 CAPSULE in 1 BOTTLE (76420-884-07) 76420-884-10 10 CAPSULE in 1 BOTTLE (76420-884-10) 76420-884-12 12 CAPSULE in 1 BOTTLE (76420-884-12) 76420-884-14 14 CAPSULE in 1 BOTTLE (76420-884-14) 76420-884-20 20 CAPSULE in 1 BOTTLE (76420-884-20) 76420-884-28 28 CAPSULE in 1 BOTTLE (76420-884-28) 76420-884-30 30 CAPSULE in 1 BOTTLE (76420-884-30) 76420-884-60 60 CAPSULE in 1 BOTTLE (76420-884-60) 76420-884-90 90 CAPSULE in 1 BOTTLE (76420-884-90)

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": "2b480a86-eebf-c37e-e063-6394a90ae54b", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["ee3f300a-d6d3-49c4-bd60-425f04d30b88"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (76420-884-00)", "package_ndc": "76420-884-00", "marketing_start_date": "20241217"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-884-01)", "package_ndc": "76420-884-01", "marketing_start_date": "20241217"}, {"sample": false, "description": "7 CAPSULE in 1 BOTTLE (76420-884-07)", "package_ndc": "76420-884-07", "marketing_start_date": "20241217"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (76420-884-10)", "package_ndc": "76420-884-10", "marketing_start_date": "20250109"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE (76420-884-12)", "package_ndc": "76420-884-12", "marketing_start_date": "20241217"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (76420-884-14)", "package_ndc": "76420-884-14", "marketing_start_date": "20241217"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-884-20)", "package_ndc": "76420-884-20", "marketing_start_date": "20241217"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (76420-884-28)", "package_ndc": "76420-884-28", "marketing_start_date": "20241217"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-884-30)", "package_ndc": "76420-884-30", "marketing_start_date": "20241217"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-884-60)", "package_ndc": "76420-884-60", "marketing_start_date": "20241217"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-884-90)", "package_ndc": "76420-884-90", "marketing_start_date": "20241217"}], "brand_name": "NITROFURANTOIN (monohydrate/macrocrystals)", "product_id": "76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "76420-884", "generic_name": "Nitrofurantoin (monohydrate/macrocrystals)", "labeler_name": "Asclemed USA, 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"}