NDC 47335-317

XELPROS

Latanoprost

XELPROS is a Ophthalmic; Topical Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Latanoprost.

• Product ID: 47335-317_0e3c5b8f-55d5-46bf-aee5-a041d59f204f
• NDC: 47335-317
• Product Type: Human Prescription Drug
• Proprietary Name: XELPROS
• Generic Name: Latanoprost
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC; TOPICAL
• Marketing Start Date: 2018-09-11
• Marketing Category: NDA / NDA
• Application Number: NDA206185
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: LATANOPROST
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Prostaglandin Analog [EPC], Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 47335-317-90

1 BOTTLE, DROPPER in 1 BOX (47335-317-90) > 2.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-09-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47335-317-92 [47335031792]

XELPROS SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA206185
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-12

NDC 47335-317-98 [47335031798]

XELPROS SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA206185
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-12

NDC 47335-317-94 [47335031794]

XELPROS SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA206185
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-12

NDC 47335-317-90 [47335031790]

XELPROS SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA206185
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-12

Drug Details

Active Ingredients

Ingredient	Strength
LATANOPROST	.05 mg/mL

OpenFDA Data

• SPL SET ID: 34ad5cf6-4df0-4104-bddd-4c7631133ded
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 6Z5B6HVF6O
• RxNorm Concept Unique ID - RxCUI:
  • 2056748
  • 2056743
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
47335-317	XELPROS	latanoprost
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
0013-8303	Xalatan	latanoprost