lactulose

Generic: lactulose

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lactulose
Generic Name lactulose
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-002
Product ID 68999-002_437b8b21-3264-1b6c-e063-6294a90a1d51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209517
Listing Expiration 2026-12-31
Marketing Start 2018-11-23

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 68999002
Hyphenated Format 68999-002

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 ANDA209517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68999-002-51)
source: ndc

Packages (1)

68999-002-24 2 TRAY in 1 BOX (68999-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68999-002-51)

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": "437b8b21-3264-1b6c-e063-6294a90a1d51", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["887157ba-3c91-4fbf-bb12-b49c6fa4252c"], "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": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-002-24)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68999-002-51)", "package_ndc": "68999-002-24", "marketing_start_date": "20251029"}], "brand_name": "Lactulose", "product_id": "68999-002_437b8b21-3264-1b6c-e063-6294a90a1d51", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "68999-002", "generic_name": "Lactulose", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA209517", "marketing_category": "ANDA", "marketing_start_date": "20181123", "listing_expiration_date": "20261231"}