Gentamicin Sulfate

Product NDC
66267-971
11-digit product format
662670971
Labeler code
66267
Product ID
66267-971_1fa7c294-f28b-210b-e063-6294a90aebc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA064163
Marketing category
ANDA
Marketing start
2006-12-13
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-971-05Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
66267-971-05Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-971-05ML - Milliliter66267-9717433b913-65be-412a-97d3-835a2a66696612017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-971GENTAMICIN SULFATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240816_4add8f7b-48f0-6b6a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN4add8f7b-48f0-6b6a-e054-00144ff88e884
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD4add8f7b-48f0-6b6a-e054-00144ff88e884
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY4add8f7b-48f0-6b6a-e054-00144ff88e884
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY4add8f7b-48f0-6b6a-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-971-05662670971051 BOTTLE, DROPPER in 1 CARTON (66267-971-05) / 5 mL in 1 BOTTLE, DROPPER2017-03-160000-00-00NoNoCurrent