Gentamicin Sulfate

Product NDC
71205-333
11-digit product format
712050333
Labeler code
71205
Product ID
71205-333_f7b2d19f-57fe-4aae-a6be-c9f4525e1438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA062196
Marketing category
ANDA
Marketing start
1996-04-05
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentamicin Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTAMICIN SULFATE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui310467

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-333-05Gentamicin Sulfate5 mL in 1 BOTTLE, PLASTICSOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-333-05ML - Milliliter71205-3332def3409-36d2-414b-bd2f-0229bb18382d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-333GENTAMICIN SULFATE SOLUTION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20250511_5193ed8d-44c9-46fe-924d-93aaea922cfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY5193ed8d-44c9-46fe-924d-93aaea922cfd3
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY5193ed8d-44c9-46fe-924d-93aaea922cfd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-333-05712050333055 mL in 1 BOTTLE, PLASTIC (71205-333-05) 5 ml2019-09-010000-00-00NoNoCurrent