Gentamicin Sulfate

Product NDC
53217-229
11-digit product format
532170229
Labeler code
53217
Product ID
53217-229_a65eb341-e2eb-43fc-94e5-b0b995459f57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA064163
Marketing category
ANDA
Marketing start
2006-12-13
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-229-012020-01-31C16284748780-19d75b9d0-81d6-f424-e053-dadaa90a57ceGentamicin Sulfate Ophthalmic Solution USP, 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-229-01Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS11
53217-229-01Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-229-01ML - Milliliter53217-229950fdede-fa69-4d17-af05-48d02ad4c6c512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-229GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170220_32c24dd7-11d4-420a-afee-a6e37baa4d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN32c24dd7-11d4-420a-afee-a6e37baa4d0f1
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD32c24dd7-11d4-420a-afee-a6e37baa4d0f1
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY32c24dd7-11d4-420a-afee-a6e37baa4d0f1
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY32c24dd7-11d4-420a-afee-a6e37baa4d0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-229-01532170229011 in 1 CARTONHistorical