Gentak

Product NDC
50090-4770
11-digit product format
500904770
Labeler code
50090
Product ID
50090-4770_a1da772b-aeb7-452c-b1ad-57299edac18f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA064093
Marketing category
ANDA
Marketing start
2006-05-08
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4770-02023-01-30C16284748780-1f386c64a-13c1-0266-e053-dadaa90a7c1aGENTAK ® Gentamicin Sulfate Ophthalmic Ointment USP,03%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4770-0Gentak3.5 g in 1 TUBEOINTMENT3.51
50090-4770-0Gentak1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4770GENTAK (GENTAMICIN SULFATE) OINTMENT [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210602_89deaa8c-74d9-4916-ae0d-6c2b908b078c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545236GENTAK 0.3 % (3 MG/GM) Ophthalmic OintmentPSN89deaa8c-74d9-4916-ae0d-6c2b908b078c1
310466gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic OintmentPSN89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]SBD89deaa8c-74d9-4916-ae0d-6c2b908b078c1
310466gentamicin 0.003 MG/MG Ophthalmic OintmentSCD89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 0.003 MG/MG Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 0.3 % Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 3 MG per 1 GM Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
310466gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4770-0500904770001 TUBE in 1 CARTON (50090-4770-0) > 3.5 g in 1 TUBE1 tube2019-12-020000-00-00NoNoCurrent