macrodantin

Generic: nitrofurantoin macrocrystals

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name macrodantin
Generic Name nitrofurantoin macrocrystals
Labeler almatica pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-288
Product ID 52427-288_37d894c9-0d78-8459-4007-55c1a006bc2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016620
Listing Expiration 2026-12-31
Marketing Start 2010-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427288
Hyphenated Format 52427-288

Supplemental Identifiers

RxCUI
201882 201883 207791 311994 311995 1648759
UPC
0352427288012 0352427287015 0352427286018
UNII
927AH8112L
NUI
N0000175494 M0014892

Packaging Origin

Original Packager
true

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 macrodantin (source: ndc)
Generic Name nitrofurantoin macrocrystals (source: ndc)
Application Number NDA016620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01)
source: ndc

Packages (1)

52427-288-01 100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

Macrodantin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37d894c9-0d78-8459-4007-55c1a006bc2e", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0352427288012", "0352427287015", "0352427286018"], "unii": ["927AH8112L"], "rxcui": ["201882", "201883", "207791", "311994", "311995", "1648759"], "spl_set_id": ["89d8696b-f9ce-9691-6222-8416ca143bba"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01)", "package_ndc": "52427-288-01", "marketing_start_date": "20100927"}], "brand_name": "Macrodantin", "product_id": "52427-288_37d894c9-0d78-8459-4007-55c1a006bc2e", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "52427-288", "generic_name": "Nitrofurantoin macrocrystals", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Macrodantin", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "NDA016620", "marketing_category": "NDA", "marketing_start_date": "20100927", "listing_expiration_date": "20261231"}