generlac

Generic: lactulose

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name generlac
Generic Name lactulose
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-892
Product ID 62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074603
Listing Expiration 2026-12-31
Marketing Start 1996-10-31

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 62135892
Hyphenated Format 62135-892

Supplemental Identifiers

RxCUI
391937 544455
UPC
0362135892470
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 generlac (source: ndc)
Generic Name lactulose (source: ndc)
Application Number ANDA074603 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (62135-892-47)
  • 946 mL in 1 BOTTLE (62135-892-94)
source: ndc

Packages (2)

62135-892-47 473 mL in 1 BOTTLE (62135-892-47) 62135-892-94 946 mL in 1 BOTTLE (62135-892-94)

Ingredients (1)

lactulose (10 g/15mL)

Linked Drug Pages (1)

Generlac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RECTAL"], "spl_id": "1d600b06-58c7-b83e-e063-6294a90a86f9", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "upc": ["0362135892470"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937", "544455"], "spl_set_id": ["35207edd-a5fe-4369-a079-7a8b0d2f2e91"], "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 RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (62135-892-47)", "package_ndc": "62135-892-47", "marketing_start_date": "20240710"}, {"sample": false, "description": "946 mL in 1 BOTTLE (62135-892-94)", "package_ndc": "62135-892-94", "marketing_start_date": "20240710"}], "brand_name": "Generlac", "product_id": "62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "62135-892", "generic_name": "Lactulose", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Generlac", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA074603", "marketing_category": "ANDA", "marketing_start_date": "19961031", "listing_expiration_date": "20261231"}