nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2254
Product ID 71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a
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 713352254
Hyphenated Format 71335-2254

Supplemental Identifiers

RxCUI
311995
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
  • 50 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (71335-2254-1)
  • 40 CAPSULE in 1 BOTTLE (71335-2254-2)
  • 20 CAPSULE in 1 BOTTLE (71335-2254-3)
  • 90 CAPSULE in 1 BOTTLE (71335-2254-4)
  • 30 CAPSULE in 1 BOTTLE (71335-2254-5)
  • 12 CAPSULE in 1 BOTTLE (71335-2254-6)
source: ndc

Packages (6)

71335-2254-1 28 CAPSULE in 1 BOTTLE (71335-2254-1) 71335-2254-2 40 CAPSULE in 1 BOTTLE (71335-2254-2) 71335-2254-3 20 CAPSULE in 1 BOTTLE (71335-2254-3) 71335-2254-4 90 CAPSULE in 1 BOTTLE (71335-2254-4) 71335-2254-5 30 CAPSULE in 1 BOTTLE (71335-2254-5) 71335-2254-6 12 CAPSULE in 1 BOTTLE (71335-2254-6)

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": "7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311995"], "spl_set_id": ["af291b9c-d1b4-42c3-a1e9-bdf3b63fd7e6"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (71335-2254-1)", "package_ndc": "71335-2254-1", "marketing_start_date": "20231002"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE (71335-2254-2)", "package_ndc": "71335-2254-2", "marketing_start_date": "20231002"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71335-2254-3)", "package_ndc": "71335-2254-3", "marketing_start_date": "20231002"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71335-2254-4)", "package_ndc": "71335-2254-4", "marketing_start_date": "20231002"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71335-2254-5)", "package_ndc": "71335-2254-5", "marketing_start_date": "20231002"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE (71335-2254-6)", "package_ndc": "71335-2254-6", "marketing_start_date": "20231002"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "71335-2254", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA217272", "marketing_category": "ANDA", "marketing_start_date": "20230321", "listing_expiration_date": "20261231"}