polyethylene glycol 3350 nf

Generic: polyethylene glycol 3350

Labeler: sunrise pharmaceutical, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350 nf
Generic Name polyethylene glycol 3350
Labeler sunrise pharmaceutical, inc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
SUNRISE PHARMACEUTICAL, INC

Identifiers & Regulatory

Product NDC 11534-180
Product ID 11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206105
Listing Expiration 2026-12-31
Marketing Start 2017-06-13

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 11534180
Hyphenated Format 11534-180

Supplemental Identifiers

RxCUI
876193
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 polyethylene glycol 3350 nf (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number ANDA206105 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 119 g in 1 BOTTLE (11534-180-19)
  • 238 g in 1 BOTTLE (11534-180-28)
  • 510 g in 1 BOTTLE (11534-180-50)
source: ndc

Packages (3)

11534-180-19 119 g in 1 BOTTLE (11534-180-19) 11534-180-28 238 g in 1 BOTTLE (11534-180-28) 11534-180-50 510 g in 1 BOTTLE (11534-180-50)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

POLYETHYLENE GLYCOL 3350 NF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "020b7f87-0f3a-4223-a402-dea12a6c53d2", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["ce5197a1-2677-4ffb-aef2-9221b28ebd23"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["SUNRISE PHARMACEUTICAL, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "119 g in 1 BOTTLE (11534-180-19)", "package_ndc": "11534-180-19", "marketing_start_date": "20170613"}, {"sample": false, "description": "238 g in 1 BOTTLE (11534-180-28)", "package_ndc": "11534-180-28", "marketing_start_date": "20170613"}, {"sample": false, "description": "510 g in 1 BOTTLE (11534-180-50)", "package_ndc": "11534-180-50", "marketing_start_date": "20170613"}], "brand_name": "POLYETHYLENE GLYCOL 3350 NF", "product_id": "11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "11534-180", "generic_name": "polyethylene glycol 3350", "labeler_name": "SUNRISE PHARMACEUTICAL, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "POLYETHYLENE GLYCOL 3350 NF", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA206105", "marketing_category": "ANDA", "marketing_start_date": "20170613", "listing_expiration_date": "20261231"}