nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-131
Product ID 82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d
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 82804131
Hyphenated Format 82804-131

Supplemental Identifiers

RxCUI
1648759
UPC
0382804131143
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 (82804-131-14)
  • 20 CAPSULE in 1 BOTTLE (82804-131-20)
  • 28 CAPSULE in 1 BOTTLE (82804-131-28)
source: ndc

Packages (3)

82804-131-14 14 CAPSULE in 1 BOTTLE (82804-131-14) 82804-131-20 20 CAPSULE in 1 BOTTLE (82804-131-20) 82804-131-28 28 CAPSULE in 1 BOTTLE (82804-131-28)

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": "4eb40c9f-799b-42e9-9979-83461983cb6d", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0382804131143"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["ef7053f3-3081-49c4-9c78-d40a01177fd9"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (82804-131-14)", "package_ndc": "82804-131-14", "marketing_start_date": "20240729"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (82804-131-20)", "package_ndc": "82804-131-20", "marketing_start_date": "20240724"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (82804-131-28)", "package_ndc": "82804-131-28", "marketing_start_date": "20240729"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "82804-131", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Proficient Rx LP", "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"}