nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

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

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3827
Product ID 70518-3827_3f66ecaf-4520-5734-e063-6294a90aecaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2026-12-31
Marketing Start 2023-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183827
Hyphenated Format 70518-3827

Supplemental Identifiers

RxCUI
1648759
UNII
927AH8112L
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 macrocrystals (source: ndc)
Generic Name nitrofurantoin macrocrystals (source: ndc)
Application Number ANDA217272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-0)
  • 6 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-1)
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-2)
source: ndc

Packages (3)

70518-3827-0 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-0) 70518-3827-1 6 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-1) 70518-3827-2 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-2)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

nitrofurantoin macrocrystals ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f66ecaf-4520-5734-e063-6294a90aecaf", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a1"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-0)", "package_ndc": "70518-3827-0", "marketing_start_date": "20230812"}, {"sample": false, "description": "6 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-1)", "package_ndc": "70518-3827-1", "marketing_start_date": "20250128"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-2)", "package_ndc": "70518-3827-2", "marketing_start_date": "20250130"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "70518-3827_3f66ecaf-4520-5734-e063-6294a90aecaf", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70518-3827", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA217272", "marketing_category": "ANDA", "marketing_start_date": "20230812", "listing_expiration_date": "20261231"}