nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler lupin pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-642
Product ID 43386-642_2e7ec48f-d605-4e97-8620-299e5f143026
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203233
Listing Expiration 2026-12-31
Marketing Start 2018-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386642
Hyphenated Format 43386-642

Supplemental Identifiers

RxCUI
311995 1648759
UPC
0343386642106 0343386642014 0343386641109 0343386641017
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 ANDA203233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (43386-642-01)
source: ndc

Packages (1)

43386-642-01 100 CAPSULE in 1 BOTTLE (43386-642-01)

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": "2e7ec48f-d605-4e97-8620-299e5f143026", "openfda": {"nui": ["N0000175494", "M0014892"], "upc": ["0343386642106", "0343386642014", "0343386641109", "0343386641017"], "unii": ["927AH8112L"], "rxcui": ["311995", "1648759"], "spl_set_id": ["52168b36-4e95-4d5b-82be-bbb91c7dcb90"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (43386-642-01)", "package_ndc": "43386-642-01", "marketing_start_date": "20180709"}], "brand_name": "Nitrofurantoin macrocrystals", "product_id": "43386-642_2e7ec48f-d605-4e97-8620-299e5f143026", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "43386-642", "generic_name": "Nitrofurantoin macrocrystals", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrofurantoin macrocrystals", "active_ingredients": [{"name": "NITROFURANTOIN", "strength": "100 mg/1"}], "application_number": "ANDA203233", "marketing_category": "ANDA", "marketing_start_date": "20180709", "listing_expiration_date": "20261231"}