FDA.reportPublic FDA data

XELPROS

Product NDC
47335-317
11-digit product format
473350317
Labeler code
47335
Product ID
47335-317_44b8ddc0-81dc-4613-bbe8-0da960cc179c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC; TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA206185
Marketing category
NDA
Marketing start
2018-09-12
Substance
LATANOPROST
Active strength
.05 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XELPROS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6Z5B6HVF6O
Rxcui2056743, 2056748

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d59b88b-5059-46d6-8e48-d5d9371caa10Product name220260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86Product name420250729
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
203382e3-d801-4f70-866f-ebe316583560Product name120190624
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-317-90XELPROS2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.511
47335-317-90XELPROS1 in 1 BOXSOLUTION/ DROPS111
47335-317-92XELPROS3 in 1 BOXSOLUTION/ DROPS311
47335-317-92XELPROS2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.511
47335-317-94XELPROS2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.511
47335-317-94XELPROS3 in 1 BOXSOLUTION/ DROPS311
47335-317-98XELPROS2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.511
47335-317-98XELPROS1 in 1 BOXSOLUTION/ DROPS111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-317-90ML - Milliliter47335-31718258911-7ae3-4016-b245-de3f64e050b512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-317XELPROS (LATANOPROST) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 8 package rows20241222_34ad5cf6-4df0-4104-bddd-4c7631133ded.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056743latanoprost 0.005 % Ophthalmic EmulsionPSN34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056748Xelprox 0.005 % Ophthalmic EmulsionPSN34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056748latanoprost 0.05 MG/ML Ophthalmic Suspension [Xelpros]SBD34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056743latanoprost 0.05 MG/ML Ophthalmic SuspensionSCD34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056743latanoprost 0.05 MG/ML Ophthalmic EmulsionSY34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056748Xelpros 0.05 MG/ML Ophthalmic EmulsionSY34ad5cf6-4df0-4104-bddd-4c7631133ded11
2056748Xelpros 0.05 MG/ML Ophthalmic SuspensionSY34ad5cf6-4df0-4104-bddd-4c7631133ded11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-317-90473350317901 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER2018-09-120000-00-00NoNoCurrent
47335-317-92473350317923 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER2018-09-120000-00-00NoNoCurrent
47335-317-94473350317943 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPER2018-09-120000-00-00YesNoCurrent
47335-317-98473350317981 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPER2018-09-120000-00-00YesNoCurrent