nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-623
Product ID 50268-623_4ba7ff07-0f36-ca5d-e063-6394a90a3357
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073671
Listing Expiration 2027-12-31
Marketing Start 2017-12-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268623
Hyphenated Format 50268-623

Supplemental Identifiers

RxCUI
311995 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 ANDA073671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15) / 1 CAPSULE in 1 BLISTER PACK (50268-623-11)
source: ndc

Packages (1)

50268-623-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15) / 1 CAPSULE in 1 BLISTER PACK (50268-623-11)

Ingredients (1)

nitrofurantoin (50 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": "4ba7ff07-0f36-ca5d-e063-6394a90a3357", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311995", "1648759"], "spl_set_id": ["650f3c60-d45d-4358-a388-7efee4ad0497"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-623-11)", "package_ndc": "50268-623-15", "marketing_start_date": "20171208"}], "brand_name": "Nitrofurantoin Macrocrystals", "product_id": "50268-623_4ba7ff07-0f36-ca5d-e063-6394a90a3357", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "50268-623", "generic_name": "Nitrofurantoin Macrocrystals", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin Macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA073671", "marketing_category": "ANDA", "marketing_start_date": "20171208", "listing_expiration_date": "20271231"}