enulose

Generic: lactulose

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enulose
Generic Name lactulose
Labeler actavis pharma, inc.
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-438
Product ID 45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090502
Listing Expiration 2026-12-31
Marketing Start 2011-02-28

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 45963438
Hyphenated Format 45963-438

Supplemental Identifiers

RxCUI
391937 755470
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 enulose (source: ndc)
Generic Name lactulose (source: ndc)
Application Number ANDA090502 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (45963-438-64)
source: ndc

Packages (1)

45963-438-64 473 mL in 1 BOTTLE (45963-438-64)

Ingredients (1)

lactulose (10 g/15mL)

Linked Drug Pages (1)

Enulose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RECTAL"], "spl_id": "bda4ccaa-fa33-4911-b3bd-12391c365f47", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937", "755470"], "spl_set_id": ["00c42c5c-d19e-4130-aa08-a8bbd47d3e5b"], "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": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (45963-438-64)", "package_ndc": "45963-438-64", "marketing_start_date": "20110228"}], "brand_name": "Enulose", "product_id": "45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "45963-438", "generic_name": "Lactulose", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enulose", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA090502", "marketing_category": "ANDA", "marketing_start_date": "20110228", "listing_expiration_date": "20261231"}