nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1170
Product ID 70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205005
Listing Expiration 2026-12-31
Marketing Start 2018-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711170
Hyphenated Format 70771-1170

Supplemental Identifiers

RxCUI
311995 1648759
UPC
0370771117017
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 nitrofurantoin macrocrystals (source: ndc)
Generic Name nitrofurantoin macrocrystals (source: ndc)
Application Number ANDA205005 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (70771-1170-0)
  • 100 CAPSULE in 1 BOTTLE (70771-1170-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1170-2) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

70771-1170-0 1000 CAPSULE in 1 BOTTLE (70771-1170-0) 70771-1170-1 100 CAPSULE in 1 BOTTLE (70771-1170-1) 70771-1170-2 10 BLISTER PACK in 1 CARTON (70771-1170-2) / 10 CAPSULE in 1 BLISTER PACK

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": "a2deefdc-9b32-44e4-a6bc-4eeae30e5c46", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0370771117017"], "unii": ["927AH8112L"], "rxcui": ["311995", "1648759"], "spl_set_id": ["8124bb9f-66af-4251-86b0-d1c247cdcb63"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (70771-1170-0)", "package_ndc": "70771-1170-0", "marketing_start_date": "20180215"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70771-1170-1)", "package_ndc": "70771-1170-1", "marketing_start_date": "20180215"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1170-2)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1170-2", "marketing_start_date": "20180215"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70771-1170", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "50 mg/1"}], "application_number": "ANDA205005", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}