lactulose

Generic: lactulose

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose
Generic Name lactulose
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-107
Product ID 82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928deb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074623
Listing Expiration 2026-12-31
Marketing Start 2019-12-03

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 82804107
Hyphenated Format 82804-107

Supplemental Identifiers

RxCUI
391937
UPC
0382804107476
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 (source: ndc)
Generic Name lactulose (source: ndc)
Application Number ANDA074623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (82804-107-47)
source: ndc

Packages (1)

82804-107-47 473 mL in 1 BOTTLE (82804-107-47)

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": "6bbabdc6-f6a8-4f67-a448-e452d1928deb", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "upc": ["0382804107476"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["6bbabdc6-f6a8-4f67-a448-e452d1928deb"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (82804-107-47)", "package_ndc": "82804-107-47", "marketing_start_date": "20240614"}], "brand_name": "LACTULOSE", "product_id": "82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928deb", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "82804-107", "generic_name": "Lactulose", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACTULOSE", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA074623", "marketing_category": "ANDA", "marketing_start_date": "20191203", "listing_expiration_date": "20261231"}