lactulose crystalline

Generic: lactulose

Labeler: cumberland assured products inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose crystalline
Generic Name lactulose
Labeler cumberland assured products inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

lactulose 10 g/10g

Manufacturer
Cumberland Assured Products Inc.

Identifiers & Regulatory

Product NDC 85592-819
Product ID 85592-819_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074712
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

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 85592819
Hyphenated Format 85592-819

Supplemental Identifiers

RxCUI
1251190 1251194
UPC
0385592829018 0385592819019
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 crystalline (source: ndc)
Generic Name lactulose (source: ndc)
Application Number ANDA074712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 g/10g
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01)
source: ndc

Packages (1)

85592-819-30 30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01)

Ingredients (1)

lactulose (10 g/10g)

Linked Drug Pages (1)

LACTULOSE Crystalline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "upc": ["0385592829018", "0385592819019"], "unii": ["9U7D5QH5AE"], "rxcui": ["1251190", "1251194"], "spl_set_id": ["59e75426-42ae-4904-941f-009181101a8a"], "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": ["Cumberland Assured Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (85592-819-30)  / 10 g in 1 POUCH (85592-819-01)", "package_ndc": "85592-819-30", "marketing_start_date": "20250901"}], "brand_name": "LACTULOSE Crystalline", "product_id": "85592-819_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9", "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": "85592-819", "generic_name": "lactulose", "labeler_name": "Cumberland Assured Products Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LACTULOSE", "brand_name_suffix": "Crystalline", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/10g"}], "application_number": "ANDA074712", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}