GENTAMICIN SULFATE

Product NDC
52959-103
11-digit product format
529590103
Labeler code
52959
Product ID
52959-103_74c092e7-126d-57e3-e053-2a91aa0a6b94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GENTAMICIN SULFATE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc
Application
ANDA064163
Marketing category
ANDA
Marketing start
2014-08-24
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
2019-12-31
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
52959-103-002020-01-31C16284748780-19d75b9d0-63eb-f424-e053-dadaa90a57ce0103-00

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-103-00GENTAMICIN SULFATE5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-103-00ML - Milliliter52959-1035338f703-ade6-4510-9929-8a200707c37512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-103GENTAMICIN SULFATE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC]1Legacy NDC, 1 package rows20180901_74c092e7-126c-57e3-e053-2a91aa0a6b94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN74c092e7-126c-57e3-e053-2a91aa0a6b941
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD74c092e7-126c-57e3-e053-2a91aa0a6b941
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY74c092e7-126c-57e3-e053-2a91aa0a6b941
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY74c092e7-126c-57e3-e053-2a91aa0a6b941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-103-00529590103005 mL in 1 BOTTLE, DROPPER5 mlHistorical