Nitrofurantoin (monohydrate/macrocrystals)

Generic: Nitrofurantoin monohydrate/macrocrystals

Labeler: American Health Packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Nitrofurantoin (monohydrate/macrocrystals)
Generic Name Nitrofurantoin monohydrate/macrocrystals
Labeler American Health Packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

NITROFURANTOIN 25 mg/1, NITROFURANTOIN MONOHYDRATE 75 mg/1

Identifiers & Regulatory

Product NDC 60687-633
Product ID 60687-633_313fe40d-0be7-a91a-e063-6294a90ae6ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207372
Marketing Start 2022-09-01
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687633
Hyphenated Format 60687-633

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 ANDA207372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-633-01) / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)
  • 50 BLISTER PACK in 1 CARTON (60687-633-65) / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)
source: ndc

Packages (2)

60687-633-01 100 BLISTER PACK in 1 CARTON (60687-633-01) / 1 CAPSULE in 1 BLISTER PACK (60687-633-11) 60687-633-65 50 BLISTER PACK in 1 CARTON (60687-633-65) / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)

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": "313fe40d-0be7-a91a-e063-6294a90ae6ec", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L", "E1QI2CQQ1I"], "rxcui": ["1648755"], "spl_set_id": ["cbbab15e-f4ec-4455-b577-58caaa7915e8"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-633-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)", "package_ndc": "60687-633-01", "marketing_end_date": "20260228", "marketing_start_date": "20220901"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (60687-633-65)  / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)", "package_ndc": "60687-633-65", "marketing_end_date": "20260228", "marketing_start_date": "20230601"}], "brand_name": "Nitrofurantoin (monohydrate/macrocrystals)", "product_id": "60687-633_313fe40d-0be7-a91a-e063-6294a90ae6ec", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]", "Nitrofurans [CS]"], "product_ndc": "60687-633", "generic_name": "Nitrofurantoin monohydrate/macrocrystals", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin", "brand_name_suffix": "(monohydrate/macrocrystals)", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "25 mg/1"}, {"name": "NITROFURANTOIN MONOHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA207372", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20220901"}