lactulose solution

Generic: lactulose solution usp, 10 g/15 ml

Labeler: bajaj medical, llc
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 bajaj medical, llc
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

lactulose 10 g/15mL

Manufacturer
Bajaj Medical, LLC

Identifiers & Regulatory

Product NDC 61037-471
Product ID 61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076645
Listing Expiration 2026-12-31
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 61037471
Hyphenated Format 61037-471

Supplemental Identifiers

RxCUI
391937
UPC
0361037471059 0361037471042 0361037471066 0361037471141 0361037471035 0361037471127
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
  • 236 mL in 1 BOTTLE (61037-471-02)
  • 946 mL in 1 BOTTLE (61037-471-03)
  • 1893 mL in 1 JUG (61037-471-04)
  • 15 mL in 1 CUP, UNIT-DOSE (61037-471-05)
  • 3785 mL in 1 JUG (61037-471-06)
  • 473 mL in 1 BOTTLE (61037-471-12)
  • 118 mL in 1 BOTTLE (61037-471-13)
  • 30 mL in 1 CUP, UNIT-DOSE (61037-471-14)
source: ndc

Packages (8)

61037-471-02 236 mL in 1 BOTTLE (61037-471-02) 61037-471-03 946 mL in 1 BOTTLE (61037-471-03) 61037-471-04 1893 mL in 1 JUG (61037-471-04) 61037-471-05 15 mL in 1 CUP, UNIT-DOSE (61037-471-05) 61037-471-06 3785 mL in 1 JUG (61037-471-06) 61037-471-12 473 mL in 1 BOTTLE (61037-471-12) 61037-471-13 118 mL in 1 BOTTLE (61037-471-13) 61037-471-14 30 mL in 1 CUP, UNIT-DOSE (61037-471-14)

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": "f0b79991-a87f-2b4b-e053-2995a90a8690", "openfda": {"nui": ["N0000175811", "N0000010288", "N0000175833", "N0000009871"], "upc": ["0361037471059", "0361037471042", "0361037471066", "0361037471141", "0361037471035", "0361037471127"], "unii": ["9U7D5QH5AE"], "rxcui": ["391937"], "spl_set_id": ["d460b1a2-9091-2ac9-e053-2995a90aa1d2"], "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": ["Bajaj Medical, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE (61037-471-02)", "package_ndc": "61037-471-02", "marketing_start_date": "20211014"}, {"sample": false, "description": "946 mL in 1 BOTTLE (61037-471-03)", "package_ndc": "61037-471-03", "marketing_start_date": "20211014"}, {"sample": false, "description": "1893 mL in 1 JUG (61037-471-04)", "package_ndc": "61037-471-04", "marketing_start_date": "20211014"}, {"sample": false, "description": "15 mL in 1 CUP, UNIT-DOSE (61037-471-05)", "package_ndc": "61037-471-05", "marketing_start_date": "20211014"}, {"sample": false, "description": "3785 mL in 1 JUG (61037-471-06)", "package_ndc": "61037-471-06", "marketing_start_date": "20211014"}, {"sample": false, "description": "473 mL in 1 BOTTLE (61037-471-12)", "package_ndc": "61037-471-12", "marketing_start_date": "20211014"}, {"sample": false, "description": "118 mL in 1 BOTTLE (61037-471-13)", "package_ndc": "61037-471-13", "marketing_start_date": "20211014"}, {"sample": false, "description": "30 mL in 1 CUP, UNIT-DOSE (61037-471-14)", "package_ndc": "61037-471-14", "marketing_start_date": "20211014"}], "brand_name": "Lactulose Solution", "product_id": "61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "61037-471", "generic_name": "Lactulose Solution USP, 10 g/15 mL", "labeler_name": "Bajaj Medical, LLC", "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": "20261231"}