nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 50 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-559
Product ID 68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd
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 68382559
Hyphenated Format 68382-559

Supplemental Identifiers

RxCUI
311995 1648759
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
  • 100 CAPSULE in 1 BOTTLE (68382-559-01)
  • 1000 CAPSULE in 1 BOTTLE (68382-559-10)
  • 10 BLISTER PACK in 1 CARTON (68382-559-30) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

68382-559-01 100 CAPSULE in 1 BOTTLE (68382-559-01) 68382-559-10 1000 CAPSULE in 1 BOTTLE (68382-559-10) 68382-559-30 10 BLISTER PACK in 1 CARTON (68382-559-30) / 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": "0d11f48c-867f-471c-a74c-9d50f6a76cfd", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311995", "1648759"], "spl_set_id": ["2862e49a-66e9-4418-9343-4404036775fc"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-559-01)", "package_ndc": "68382-559-01", "marketing_start_date": "20180215"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (68382-559-10)", "package_ndc": "68382-559-10", "marketing_start_date": "20180215"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-559-30)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "68382-559-30", "marketing_start_date": "20180215"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "68382-559", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "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"}