lactulose

Generic: lactulose

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose
Generic Name lactulose
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4243
Product ID 51672-4243_3b8ff35a-8b5e-7aca-e063-6394a90aea34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218858
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

Pharmacologic Class

Established (EPC)
osmotic laxative [epc]
Mechanism of Action
osmotic activity [moa] acidifying activity [moa]
Physiologic Effect
stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724243
Hyphenated Format 51672-4243

Supplemental Identifiers

RxCUI
391937
UNII
9U7D5QH5AE
NUI
N0000175811 N0000010288 N0000175833 N0000009871

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 lactulose (source: ndc)
Generic Name lactulose (source: ndc)
Application Number ANDA218858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-4243-9) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-4243-9 1 BOTTLE in 1 CARTON (51672-4243-9) / 473 mL in 1 BOTTLE

Ingredients (1)

lactulose (10 g/15mL)

Linked Drug Pages (1)

Lactulose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b8ff35a-8b5e-7aca-e063-6394a90aea34", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["391cfd01-c1fa-41f9-abd7-d0abe9a27634"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]", "Acidifying Activity [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-4243-9)  / 473 mL in 1 BOTTLE", "package_ndc": "51672-4243-9", "marketing_start_date": "20250602"}], "brand_name": "Lactulose", "product_id": "51672-4243_3b8ff35a-8b5e-7aca-e063-6394a90aea34", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "51672-4243", "generic_name": "Lactulose", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA218858", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}