NDC 51134-5191

Colirio Ocusan

Polyethlene Glycol 400 Tetrahydrozoline Hcl

Colirio Ocusan is a Ophthalmic Liquid in the Human Otc Drug category. It is labeled and distributed by Samchundang Pharm. Co., Ltd.. The primary component is Polyethylene Glycol 400; Tetrahydrozoline Hydrochloride.

Product ID51134-5191_010cda0b-f66b-4598-bbb0-fdf67b810afd
NDC51134-5191
Product TypeHuman Otc Drug
Proprietary NameColirio Ocusan
Generic NamePolyethlene Glycol 400 Tetrahydrozoline Hcl
Dosage FormLiquid
Route of AdministrationOPHTHALMIC
Marketing Start Date2010-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameSamchundang Pharm. Co., Ltd.
Substance NamePOLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE
Active Ingredient Strength0 mL/15mL; mL/15mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 51134-5191-5

1 BOTTLE in 1 BOX (51134-5191-5) > 15 mL in 1 BOTTLE
Marketing Start Date2010-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51134-5191-5 [51134519105]

Colirio Ocusan LIQUID
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-08-01
Marketing End Date2019-12-31
Inactivation Date2019-10-21
Reactivation Date2020-01-08

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 400.15 mL/15mL

OpenFDA Data

SPL SET ID:36136ce4-9d66-4e56-bd51-0616a79a42a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1053111
  • 996209
  • UPC Code
  • 0324286151912
  • NDC Crossover Matching brand name "Colirio Ocusan" or generic name "Polyethlene Glycol 400 Tetrahydrozoline Hcl"

    NDCBrand NameGeneric Name
    24286-1575Colirio OcusanTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70
    24286-5191Colirio OcusanPolyethlene glycol 400 Tetrahydrozoline HCl
    51134-5191Colirio OcusanPolyethlene glycol 400 Tetrahydrozoline HCl

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