Gentamicin Sulfate

Product NDC
45865-672
11-digit product format
458650672
Labeler code
45865
Product ID
45865-672_9ab3823b-9674-f077-e053-2995a90a740b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Medsource Pharmaceuticals
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-672-012025-01-30C16284748780-12cef2736-a459-d83d-e063-dadaa90ab31fGentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-672-01Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS12
45865-672-01Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS52

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-672GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1f908b73-d829-4c6f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY1f908b73-d829-4c6f-e054-00144ff8d46c2
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY1f908b73-d829-4c6f-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-672-01458650672011 BOTTLE, DROPPER in 1 CARTON (45865-672-01) > 5 mL in 1 BOTTLE, DROPPER2015-09-150000-00-00NoNoCurrent