nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nitrofurantoin 100 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-842
Product ID 61919-842_4c4a0cbe-75d9-ecfa-e063-6394a90aeb28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2027-12-31
Marketing Start 2024-02-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919842
Hyphenated Format 61919-842

Supplemental Identifiers

RxCUI
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 ANDA217272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE (61919-842-14)
  • 20 CAPSULE in 1 BOTTLE (61919-842-20)
source: ndc

Packages (2)

61919-842-14 14 CAPSULE in 1 BOTTLE (61919-842-14) 61919-842-20 20 CAPSULE in 1 BOTTLE (61919-842-20)

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": "4c4a0cbe-75d9-ecfa-e063-6394a90aeb28", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["10d05283-e247-4e60-e063-6294a90ac292"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (61919-842-14)", "package_ndc": "61919-842-14", "marketing_start_date": "20240207"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (61919-842-20)", "package_ndc": "61919-842-20", "marketing_start_date": "20240207"}], "brand_name": "Nitrofurantoin Macrocrystals", "product_id": "61919-842_4c4a0cbe-75d9-ecfa-e063-6394a90aeb28", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "61919-842", "generic_name": "Nitrofurantoin Macrocrystals", "labeler_name": "Direct_Rx", "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": "20240207", "listing_expiration_date": "20271231"}