lactulose

Generic: lactulose

Labeler: xttrium laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose
Generic Name lactulose
Labeler xttrium laboratories, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-4005
Product ID 0116-4005_3469aba7-2ea7-f049-e063-6394a90adae4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075911
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

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 01164005
Hyphenated Format 0116-4005

Supplemental Identifiers

RxCUI
391937
UPC
0301164005086 0301164005161 0301164005321
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 ANDA075911 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (0116-4005-08)
  • 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)
  • 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)
  • 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)
  • 473 mL in 1 BOTTLE (0116-4005-16)
  • 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)
  • 946 mL in 1 BOTTLE (0116-4005-32)
source: ndc

Packages (7)

0116-4005-08 237 mL in 1 BOTTLE (0116-4005-08) 0116-4005-10 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) 0116-4005-11 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) 0116-4005-15 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) 0116-4005-16 473 mL in 1 BOTTLE (0116-4005-16) 0116-4005-30 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) 0116-4005-32 946 mL in 1 BOTTLE (0116-4005-32)

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": "3469aba7-2ea7-f049-e063-6394a90adae4", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "upc": ["0301164005086", "0301164005161", "0301164005321"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["df62ad54-5aba-4d05-e053-2a95a90aa48d"], "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": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (0116-4005-08)", "package_ndc": "0116-4005-08", "marketing_start_date": "20220701"}, {"sample": false, "description": "100 CASE in 1 CASE (0116-4005-10)  / 40 TRAY in 1 CASE (0116-4005-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)", "package_ndc": "0116-4005-10", "marketing_start_date": "20220701"}, {"sample": false, "description": "100 CASE in 1 CASE (0116-4005-11)  / 40 TRAY in 1 CASE (0116-4005-41)  / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)", "package_ndc": "0116-4005-11", "marketing_start_date": "20220701"}, {"sample": false, "description": "15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)", "package_ndc": "0116-4005-15", "marketing_start_date": "20220701"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0116-4005-16)", "package_ndc": "0116-4005-16", "marketing_start_date": "20220701"}, {"sample": false, "description": "30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)", "package_ndc": "0116-4005-30", "marketing_start_date": "20220701"}, {"sample": false, "description": "946 mL in 1 BOTTLE (0116-4005-32)", "package_ndc": "0116-4005-32", "marketing_start_date": "20220701"}], "brand_name": "Lactulose", "product_id": "0116-4005_3469aba7-2ea7-f049-e063-6394a90adae4", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0116-4005", "generic_name": "Lactulose", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA075911", "marketing_category": "ANDA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}