GENTAMICIN SULFATE

Product NDC
33261-604
11-digit product format
332610604
Labeler code
33261
Product ID
33261-604_2323a0e0-63f8-4083-bda3-2f65f374fd40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062452
Marketing category
ANDA
Marketing start
1998-01-05
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
33261-604-012020-01-31C16284748780-19d75b9cf-f1a6-f424-e053-dadaa90a57ceGENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-604-01GENTAMICIN SULFATE1 in 1 CARTONSOLUTION/ DROPS11
33261-604-01GENTAMICIN SULFATE5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-604-01ML - Milliliter33261-60450aa3506-8c67-46c6-af07-db81b8be108912015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-604GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140110_2e647e36-15d9-49e9-b81b-35465441e37a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN2e647e36-15d9-49e9-b81b-35465441e37a1
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD2e647e36-15d9-49e9-b81b-35465441e37a1
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY2e647e36-15d9-49e9-b81b-35465441e37a1
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY2e647e36-15d9-49e9-b81b-35465441e37a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-604-01332610604011 in 1 CARTONHistorical