miralax orange flavor (11523-0122)

Drug Facts

Product Profile

Brand Name miralax orange flavor

Generic Name polyethylene glycol 3350

Labeler bayer healthcare llc.

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer

Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-0122

Product ID 11523-0122_4526ca58-f032-31ad-e063-6394a90a7bae

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA090685

Listing Expiration 2026-12-31

Marketing Start 2023-09-15

Pharmacologic Class

Established (EPC)

osmotic laxative [epc]

Mechanism of Action

osmotic activity [moa]

Physiologic Effect

stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115230122

Hyphenated Format 11523-0122

Supplemental Identifiers

RxCUI

876193 876195

UPC

0041100600554

UNII

G2M7P15E5P

NUI

N0000010288 N0000175811 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 miralax orange flavor (source: ndc)

Generic Name polyethylene glycol 3350 (source: ndc)

Application Number ANDA090685 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

17 g/17g

source: ndc

Packaging

238 g in 1 BOTTLE (11523-0122-1)
119 g in 1 BOTTLE (11523-0122-2)

source: ndc

Packages (2)

11523-0122-1 238 g in 1 BOTTLE (11523-0122-1) 11523-0122-2 119 g in 1 BOTTLE (11523-0122-2)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

MiraLAX Orange Flavor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4526ca58-f032-31ad-e063-6394a90a7bae", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0041100600554"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "876195"], "spl_set_id": ["0a5b2121-928f-8f49-e063-6394a90a8aaf"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 g in 1 BOTTLE (11523-0122-1)", "package_ndc": "11523-0122-1", "marketing_start_date": "20230915"}, {"sample": false, "description": "119 g in 1 BOTTLE (11523-0122-2)", "package_ndc": "11523-0122-2", "marketing_start_date": "20230915"}], "brand_name": "MiraLAX Orange Flavor", "product_id": "11523-0122_4526ca58-f032-31ad-e063-6394a90a7bae", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "11523-0122", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MiraLAX Orange Flavor", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA090685", "marketing_category": "ANDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}