Gentamicin Sulfate

Product NDC
71205-560
11-digit product format
712050560
Labeler code
71205
Product ID
71205-560_cf4386ba-c62a-4ee8-ab59-1bb2e737a5da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA064054
Marketing category
ANDA
Marketing start
2014-11-28
Substance
GENTAMICIN SULFATE
Active strength
1 mg/g
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 SULFATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui310465

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
71205-560-15Gentamicin Sulfate1 in 1 CARTONOINTMENT11
71205-560-15Gentamicin Sulfate15 g in 1 TUBEOINTMENT151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-560-15GM - Gram71205-5607790ca4a-60b3-4bd8-9f2f-1ca30ac6235212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-560GENTAMICIN SULFATE OINTMENT [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20210508_cf4386ba-c62a-4ee8-ab59-1bb2e737a5da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310465gentamicin sulfate 0.1 % Topical OintmentPSNcf4386ba-c62a-4ee8-ab59-1bb2e737a5da1
310465gentamicin 0.001 MG/MG Topical OintmentSCDcf4386ba-c62a-4ee8-ab59-1bb2e737a5da1
310465gentamicin (as gentamicin sulfate) 0.1 % Topical OintmentSYcf4386ba-c62a-4ee8-ab59-1bb2e737a5da1
310465gentamicin sulfate 0.001 MG/MG Topical OintmentSYcf4386ba-c62a-4ee8-ab59-1bb2e737a5da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-560-15712050560151 TUBE in 1 CARTON (71205-560-15) / 15 g in 1 TUBE1 tube2021-05-060000-00-00NoNoCurrent