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 ID: 51134-5191_010cda0b-f66b-4598-bbb0-fdf67b810afd
• NDC: 51134-5191
• Product Type: Human Otc Drug
• Proprietary Name: Colirio Ocusan
• Generic Name: Polyethlene Glycol 400 Tetrahydrozoline Hcl
• Dosage Form: Liquid
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2010-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Samchundang Pharm. Co., Ltd.
• Substance Name: POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE
• Active Ingredient Strength: 0 mL/15mL; mL/15mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 51134-5191-5

1 BOTTLE in 1 BOX (51134-5191-5) > 15 mL in 1 BOTTLE

• Marketing Start Date: 2010-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51134-5191-5 [51134519105]

Colirio Ocusan LIQUID

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-08-01
• Marketing End Date: 2019-12-31
• Inactivation Date: 2019-10-21
• Reactivation Date: 2020-01-08

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 400	.15 mL/15mL

OpenFDA Data

• SPL SET ID: 36136ce4-9d66-4e56-bd51-0616a79a42a7
• Manufacturer:
  • Samchundang Pharm. Co., Ltd.
• UNII:
  • B697894SGQ
  • 0YZT43HS7D
• 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"

NDC	Brand Name	Generic Name
24286-1575	Colirio Ocusan	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70
24286-5191	Colirio Ocusan	Polyethlene glycol 400 Tetrahydrozoline HCl
51134-5191	Colirio Ocusan	Polyethlene glycol 400 Tetrahydrozoline HCl