NDC 0517-0830

Latanoprost

Latanoprost

Latanoprost is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Latanoprost.

• Product ID: 0517-0830_2db770c5-97b0-40dd-a442-d4d1be4f5df9
• NDC: 0517-0830
• Product Type: Human Prescription Drug
• Proprietary Name: Latanoprost
• Generic Name: Latanoprost
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2011-08-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200925
• Labeler Name: American Regent, Inc.
• Substance Name: LATANOPROST
• Active Ingredient Strength: 50 ug/mL
• Pharm Classes: Prostaglandin Analog [EPC],Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0517-0830-03

1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-03) > 2.5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2011-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0830-01 [00517083001]

Latanoprost SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200925
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-08-02
• Marketing End Date: 2014-09-30

NDC 0517-0830-03 [00517083003]

Latanoprost SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200925
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-02
• Marketing End Date: 2014-09-30

Drug Details

Active Ingredients

Ingredient	Strength
LATANOPROST	50 ug/mL

OpenFDA Data

• SPL SET ID: f44d3f09-fa2d-4f01-831d-71a15bde5e29
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • 6Z5B6HVF6O
• RxNorm Concept Unique ID - RxCUI:
  • 314072
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

• Prostaglandin Analog [EPC]
• Prostaglandins [Chemical/Ingredient]
• Prostaglandins [CS]

NDC Crossover Matching brand name "Latanoprost" or generic name "Latanoprost"

NDC	Brand Name	Generic Name
0517-0830	Latanoprost	Latanoprost
13985-610	Latanoprost	Latanoprost
17478-625	LATANOPROST	LATANOPROST
21695-986	Latanoprost	Latanoprost
24208-463	Latanoprost	latanoprost
50090-1240	LATANOPROST	LATANOPROST
50090-1920	Latanoprost	latanoprost
55545-1010	LATANOPROST	latanoprost
59762-0333	Latanoprost	Latanoprost
61314-547	Latanoprost	Latanoprost
61919-112	LATANOPROST	LATANOPROST
64980-516	LATANOPROST	latanoprost
65862-872	Latanoprost	Latanoprost
68071-1683	Latanoprost	Latanoprost
68071-4650	Latanoprost	Latanoprost
68071-4612	Latanoprost	Latanoprost
71205-154	Latanoprost	Latanoprost
68071-4893	LATANOPROST	LATANOPROST
70069-421	LATANOPROST	LATANOPROST
0013-8303	Xalatan	latanoprost
47335-317	XELPROS	latanoprost