lactulose solution

Generic: lactulose solution usp, 10 g/15 ml

Labeler: kesin pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose solution
Generic Name lactulose solution usp, 10 g/15 ml
Labeler kesin pharma corporation
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-241
Product ID 81033-241_2d90dbd5-a13b-3875-e063-6394a90a1dc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076645
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

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 81033241
Hyphenated Format 81033-241

Supplemental Identifiers

RxCUI
391937
UNII
9U7D5QH5AE
NUI
N0000175811 N0000010288 N0000175833 N0000009871

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 solution (source: ndc)
Generic Name lactulose solution usp, 10 g/15 ml (source: ndc)
Application Number ANDA076645 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE, PLASTIC (81033-241-32)
source: ndc

Packages (1)

81033-241-32 15 mL in 1 BOTTLE, PLASTIC (81033-241-32)

Ingredients (1)

lactulose (10 g/15mL)

Linked Drug Pages (1)

Lactulose Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RECTAL"], "spl_id": "2d90dbd5-a13b-3875-e063-6394a90a1dc0", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["2d90e2a4-334f-ab68-e063-6294a90affa6"], "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": ["Kesin Pharma Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (81033-241-32)", "package_ndc": "81033-241-32", "marketing_start_date": "20250202"}], "brand_name": "Lactulose Solution", "product_id": "81033-241_2d90dbd5-a13b-3875-e063-6394a90a1dc0", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "81033-241", "generic_name": "Lactulose Solution USP, 10 g/15 mL", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose Solution", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA076645", "marketing_category": "ANDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}