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 SOLUTION
Routes
ORAL
Active Ingredients

lactulose 20 g/30mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1154
Product ID 0121-1154_6843c997-c52c-4978-b087-647f7c3fa782
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074623
Listing Expiration 2026-12-31
Marketing Start 1966-07-30

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 01211154
Hyphenated Format 0121-1154

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 ANDA074623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 g/30mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-1154-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30)
  • 4 TRAY in 1 CASE (0121-1154-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30)
source: ndc

Packages (2)

0121-1154-00 10 TRAY in 1 CASE (0121-1154-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30) 0121-1154-40 4 TRAY in 1 CASE (0121-1154-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30)

Ingredients (1)

lactulose (20 g/30mL)

Linked Drug Pages (1)

LACTULOSE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6843c997-c52c-4978-b087-647f7c3fa782", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["0f19e4ed-c90a-4330-a7fa-bf911aa98f09"], "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": "10 TRAY in 1 CASE (0121-1154-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30)", "package_ndc": "0121-1154-00", "marketing_start_date": "20190503"}, {"sample": false, "description": "4 TRAY in 1 CASE (0121-1154-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1154-30)", "package_ndc": "0121-1154-40", "marketing_start_date": "20190503"}], "brand_name": "LACTULOSE", "product_id": "0121-1154_6843c997-c52c-4978-b087-647f7c3fa782", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0121-1154", "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/30mL"}], "application_number": "ANDA074623", "marketing_category": "ANDA", "marketing_start_date": "19660730", "listing_expiration_date": "20261231"}