nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-340
Product ID 72789-340_373a52aa-03d1-3290-e063-6294a90ae504
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2026-12-31
Marketing Start 2023-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789340
Hyphenated Format 72789-340

Supplemental Identifiers

RxCUI
1648759
UPC
0372789340104
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
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-10)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-14)
source: ndc

Packages (2)

72789-340-10 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-10) 72789-340-14 14 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-14)

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": "373a52aa-03d1-3290-e063-6294a90ae504", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0372789340104"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["f28d72be-56d7-467f-a3f8-9ffd57d0dffa"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-10)", "package_ndc": "72789-340-10", "marketing_start_date": "20230801"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (72789-340-14)", "package_ndc": "72789-340-14", "marketing_start_date": "20230811"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "72789-340_373a52aa-03d1-3290-e063-6294a90ae504", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "72789-340", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "PD-Rx Pharmaceuticals, 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": "20230321", "listing_expiration_date": "20261231"}