NDC 0065-0474

Systane

Hypromellose

Systane is a Ophthalmic Gel in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Hypromellose 2910 (4000 Mpa.s).

• Product ID: 0065-0474_1699923c-b9d5-43d0-94a5-be2cc00b05d9
• NDC: 0065-0474
• Product Type: Human Otc Drug
• Proprietary Name: Systane
• Generic Name: Hypromellose
• Dosage Form: Gel
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2012-12-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: HYPROMELLOSE 2910 (4000 MPA.S)
• Active Ingredient Strength: 3 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0065-0474-01

1 TUBE in 1 CARTON (0065-0474-01) > 10 g in 1 TUBE

• Marketing Start Date: 2012-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0474-01 [00065047401]

Systane GEL

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-12-15

NDC 0065-0474-02 [00065047402]

Systane GEL

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-12-15
• Marketing End Date: 2018-12-31

Drug Details

Active Ingredients

Ingredient	Strength
HYPROMELLOSE 2910 (4000 MPA.S)	3 mg/g

OpenFDA Data

• SPL SET ID: 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • RN3152OP35
• RxNorm Concept Unique ID - RxCUI:
  • 1363484
  • 310932

NDC Crossover Matching brand name "Systane" or generic name "Hypromellose"

NDC	Brand Name	Generic Name
0065-0431	Systane	polyethylene glycol and propylene glycol
0065-0454	Systane	polyethylene glycol 400 and propylene glycol
0065-0474	Systane	hypromellose
0065-1432	Systane	polyethylene glycol 400 and propylene glycol
0078-0429	GenTeal	HYPROMELLOSE
0078-0517	GenTeal	hypromellose
0065-8064	GenTeal Tears	Hypromellose
0536-6237	Natures Tears	Hypromellose
10742-8194	Rohto Jolt	Hypromellose
57619-303	Splash Tears	Hypromellose
77790-002	VISTA Hypromellose Dry Eye Relief	hypromellose