nitrofurantion macrocrystals

Generic: nitrofurantion macrocrystals

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

Drug Facts

Product Profile

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

nitrofurantoin 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-245
Product ID 63187-245_63156793-74b0-444c-bb12-dbe7be60ec91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016620
Listing Expiration 2026-12-31
Marketing Start 2010-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187245
Hyphenated Format 63187-245

Supplemental Identifiers

RxCUI
1648759
UPC
0363187245207
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 nitrofurantion macrocrystals (source: ndc)
Generic Name nitrofurantion macrocrystals (source: ndc)
Application Number NDA016620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28)
source: ndc

Packages (4)

63187-245-10 10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10) 63187-245-14 14 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14) 63187-245-20 20 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20) 63187-245-28 28 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28)

Ingredients (1)

nitrofurantoin (100 mg/1)

Linked Drug Pages (1)

Nitrofurantion Macrocrystals ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "63156793-74b0-444c-bb12-dbe7be60ec91", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0363187245207"], "unii": ["927AH8112L"], "rxcui": ["1648759"], "spl_set_id": ["3b53f9bf-866a-4cb1-9180-7b13896e26ba"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10)", "package_ndc": "63187-245-10", "marketing_start_date": "20140901"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14)", "package_ndc": "63187-245-14", "marketing_start_date": "20160901"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20)", "package_ndc": "63187-245-20", "marketing_start_date": "20140901"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28)", "package_ndc": "63187-245-28", "marketing_start_date": "20211208"}], "brand_name": "Nitrofurantion Macrocrystals", "product_id": "63187-245_63156793-74b0-444c-bb12-dbe7be60ec91", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "63187-245", "generic_name": "Nitrofurantion Macrocrystals", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantion Macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "NDA016620", "marketing_category": "NDA", "marketing_start_date": "20100927", "listing_expiration_date": "20261231"}