FDA.reportPublic FDA data

Gentak

Product NDC
17478-284
11-digit product format
174780284
Labeler code
17478
Product ID
17478-284_50c5ed21-5a73-40cb-aa7a-0e1ba3b7bbb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Akorn
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
2023-12-31
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
17478-284-352024-01-30C16284748780-11030e365-34b5-111a-e063-dadaa90a10e2GENTAK ® Gentamicin Sulfate Ophthalmic Ointment USP,0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-284-35Gentak1 in 1 CARTONOINTMENT16
17478-284-35Gentak3.5 g in 1 TUBEOINTMENT3.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-284-35GM - Gram17478-28489095929-33e3-404b-a9bc-e49509773ce912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
Gentamicin SulfateINACTIVE INGREDIENT8X7386QRLVGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHGENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-284GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN]6Legacy NDC, 2 package rows20220702_a357d23d-1f10-44ce-a2fa-a6a5e03e7739.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545236GENTAK 0.3 % (3 MG/GM) Ophthalmic OintmentPSNa357d23d-1f10-44ce-a2fa-a6a5e03e77396
310466gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic OintmentPSNa357d23d-1f10-44ce-a2fa-a6a5e03e77396
545236gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]SBDa357d23d-1f10-44ce-a2fa-a6a5e03e77396
310466gentamicin 0.003 MG/MG Ophthalmic OintmentSCDa357d23d-1f10-44ce-a2fa-a6a5e03e77396
545236Gentak 0.003 MG/MG Ophthalmic OintmentSYa357d23d-1f10-44ce-a2fa-a6a5e03e77396
545236Gentak 0.3 % Ophthalmic OintmentSYa357d23d-1f10-44ce-a2fa-a6a5e03e77396
545236Gentak 3 MG per 1 GM Ophthalmic OintmentSYa357d23d-1f10-44ce-a2fa-a6a5e03e77396
310466gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic OintmentSYa357d23d-1f10-44ce-a2fa-a6a5e03e77396
545236GENTAK 0.3 % (3 MG/GM) Ophthalmic OintmentPSNaebfe247-cdf7-4acb-97b3-6d4341d7c8153
310466gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic OintmentPSNaebfe247-cdf7-4acb-97b3-6d4341d7c8153
545236gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]SBDaebfe247-cdf7-4acb-97b3-6d4341d7c8153
310466gentamicin 0.003 MG/MG Ophthalmic OintmentSCDaebfe247-cdf7-4acb-97b3-6d4341d7c8153
545236Gentak 0.003 MG/MG Ophthalmic OintmentSYaebfe247-cdf7-4acb-97b3-6d4341d7c8153
545236Gentak 0.3 % Ophthalmic OintmentSYaebfe247-cdf7-4acb-97b3-6d4341d7c8153
545236Gentak 3 MG per 1 GM Ophthalmic OintmentSYaebfe247-cdf7-4acb-97b3-6d4341d7c8153
310466gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic OintmentSYaebfe247-cdf7-4acb-97b3-6d4341d7c8153
545236GENTAK 0.3 % (3 MG/GM) Ophthalmic OintmentPSN89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236GENTAK 0.3 % (3 MG/GM) Ophthalmic OintmentPSN1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
310466gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic OintmentPSN89deaa8c-74d9-4916-ae0d-6c2b908b078c1
310466gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic OintmentPSN1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
545236gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]SBD89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]SBD1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
310466gentamicin 0.003 MG/MG Ophthalmic OintmentSCD89deaa8c-74d9-4916-ae0d-6c2b908b078c1
310466gentamicin 0.003 MG/MG Ophthalmic OintmentSCD1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
545236Gentak 0.003 MG/MG Ophthalmic OintmentSY1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
545236Gentak 0.003 MG/MG Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 0.3 % Ophthalmic OintmentSY1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
545236Gentak 0.3 % Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 3 MG per 1 GM Ophthalmic OintmentSY89deaa8c-74d9-4916-ae0d-6c2b908b078c1
545236Gentak 3 MG per 1 GM Ophthalmic OintmentSY1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
310466gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic OintmentSY1ab0eecf-5ce2-c2bc-e063-6394a90a744b1
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
17478-284-35174780284351 TUBE in 1 CARTON (17478-284-35) > 3.5 g in 1 TUBE1 tube2006-05-080000-00-00NoNoCurrent