lactulose

Generic: lactulose

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose
Generic Name lactulose
Labeler pai holdings, llc dba pai pharma
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

lactulose 20 g/20g

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1930
Product ID 0121-1930_e4873a34-cdc0-4c96-b04f-c84641f52236
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217914
Listing Expiration 2026-12-31
Marketing Start 2025-03-17

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 01211930
Hyphenated Format 0121-1930

Supplemental Identifiers

RxCUI
1251190 1251194
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 ANDA217914 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 g/20g
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0121-1930-30) / 20 g in 1 POUCH (0121-1930-01)
source: ndc

Packages (1)

0121-1930-30 30 POUCH in 1 CARTON (0121-1930-30) / 20 g in 1 POUCH (0121-1930-01)

Ingredients (1)

lactulose (20 g/20g)

Linked Drug Pages (1)

Lactulose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e4873a34-cdc0-4c96-b04f-c84641f52236", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["1251190", "1251194"], "spl_set_id": ["5ae4b6da-44df-419a-9f2b-8c4d79f635c8"], "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": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0121-1930-30)  / 20 g in 1 POUCH (0121-1930-01)", "package_ndc": "0121-1930-30", "marketing_start_date": "20250317"}], "brand_name": "Lactulose", "product_id": "0121-1930_e4873a34-cdc0-4c96-b04f-c84641f52236", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0121-1930", "generic_name": "Lactulose", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose", "active_ingredients": [{"name": "LACTULOSE", "strength": "20 g/20g"}], "application_number": "ANDA217914", "marketing_category": "ANDA", "marketing_start_date": "20250317", "listing_expiration_date": "20261231"}