lactulose solution

Generic: lactulose solution usp, 10 g/15 ml

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

Drug Facts

Product Profile

Brand Name lactulose solution
Generic Name lactulose solution usp, 10 g/15 ml
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-592
Product ID 64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076645
Listing Expiration 2027-12-31
Marketing Start 2021-10-14

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 64980592
Hyphenated Format 64980-592

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 solution (source: ndc)
Generic Name lactulose solution usp, 10 g/15 ml (source: ndc)
Application Number ANDA076645 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 g/15mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (64980-592-12)
  • 236 mL in 1 BOTTLE (64980-592-24)
  • 473 mL in 1 BOTTLE (64980-592-48)
  • 946 mL in 1 BOTTLE (64980-592-95)
source: ndc

Packages (4)

64980-592-12 118 mL in 1 BOTTLE (64980-592-12) 64980-592-24 236 mL in 1 BOTTLE (64980-592-24) 64980-592-48 473 mL in 1 BOTTLE (64980-592-48) 64980-592-95 946 mL in 1 BOTTLE (64980-592-95)

Ingredients (1)

lactulose (10 g/15mL)

Linked Drug Pages (1)

Lactulose Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RECTAL"], "spl_id": "ae4387e8-ba31-4378-9e67-98effdcc998f", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["e75c335b-f19e-42e2-a24f-d891a52d3d34"], "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": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (64980-592-12)", "package_ndc": "64980-592-12", "marketing_start_date": "20230525"}, {"sample": false, "description": "236 mL in 1 BOTTLE (64980-592-24)", "package_ndc": "64980-592-24", "marketing_start_date": "20230525"}, {"sample": false, "description": "473 mL in 1 BOTTLE (64980-592-48)", "package_ndc": "64980-592-48", "marketing_start_date": "20230525"}, {"sample": false, "description": "946 mL in 1 BOTTLE (64980-592-95)", "package_ndc": "64980-592-95", "marketing_start_date": "20230525"}], "brand_name": "Lactulose Solution", "product_id": "64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "64980-592", "generic_name": "Lactulose Solution USP, 10 g/15 mL", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lactulose Solution", "active_ingredients": [{"name": "LACTULOSE", "strength": "10 g/15mL"}], "application_number": "ANDA076645", "marketing_category": "ANDA", "marketing_start_date": "20211014", "listing_expiration_date": "20271231"}