FDA.reportPublic FDA data

Goniotaire

Product NDC
59390-182
11-digit product format
593900182
Labeler code
59390
Product ID
59390-182_3e98cefc-43d0-40bf-80be-651f17a39d4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYPROMELLOSE 2906 (4000 MPA.S)
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Altaire Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2002-01-18
Marketing end
0000-00-00
Substance
HYPROMELLOSE 2906 (4000 MPA.S)
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59390-182DDiscontinued by firm2026-10-15
excluded packagepackage59390-18259390-182-13DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-182-13Goniotaire15 mL in 1 BOTTLESOLUTION153
59390-182-13Goniotaire1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-182-13ML - Milliliter59390-1828d317a1f-e2f5-4871-bd9b-db280399fff212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-182GONIOTAIRE (HYPROMELLOSE 2906 (4000 MPA.S)) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]3Legacy NDC, 2 package rows20221101_9ebedd36-523a-4f92-8fe9-33beaf7288f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310934hypromellose 2.5 % Ophthalmic SolutionPSN9ebedd36-523a-4f92-8fe9-33beaf7288f93
310934hypromellose 25 MG/ML Ophthalmic SolutionSCD9ebedd36-523a-4f92-8fe9-33beaf7288f93
310934hypromellose 2.5 % Ophthalmic SolutionSY9ebedd36-523a-4f92-8fe9-33beaf7288f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59390-182-13593900182131 BOTTLE in 1 CARTON (59390-182-13) > 15 mL in 1 BOTTLE1 bottle2002-01-180000-00-00NoNoCurrent