nitrofurantoin macrocrystals

Generic: nitrofurantoin macrocrystals

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrofurantoin macrocrystals
Generic Name nitrofurantoin macrocrystals
Labeler lifestar pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitrofurantoin 100 mg/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-412
Product ID 70756-412_9add55a0-f57d-473d-9e83-ceffe099a1b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217272
Listing Expiration 2026-12-31
Marketing Start 2023-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756412
Hyphenated Format 70756-412

Supplemental Identifiers

RxCUI
311994 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 ANDA217272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70756-412-11)
source: ndc

Packages (1)

70756-412-11 100 CAPSULE in 1 BOTTLE (70756-412-11)

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": "9add55a0-f57d-473d-9e83-ceffe099a1b1", "openfda": {"nui": ["N0000175494", "M0014892"], "unii": ["927AH8112L"], "rxcui": ["311994", "311995", "1648759"], "spl_set_id": ["6ec66cc8-938f-4839-98c7-a51c9f1d50ed"], "pharm_class_cs": ["Nitrofurans [CS]"], "pharm_class_epc": ["Nitrofuran Antibacterial [EPC]"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70756-412-11)", "package_ndc": "70756-412-11", "marketing_start_date": "20230321"}], "brand_name": "nitrofurantoin macrocrystals", "product_id": "70756-412_9add55a0-f57d-473d-9e83-ceffe099a1b1", "dosage_form": "CAPSULE", "pharm_class": ["Nitrofuran Antibacterial [EPC]", "Nitrofurans [CS]"], "product_ndc": "70756-412", "generic_name": "nitrofurantoin macrocrystals", "labeler_name": "Lifestar Pharma LLC", "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": "20230321", "listing_expiration_date": "20261231"}