FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
0713-0682
11-digit product format
007130682
Labeler code
0713
Product ID
0713-0682_0acd2432-98da-018e-e063-6294a90ad373
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
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
0713-0682-15Gentamicin Sulfate1 in 1 CARTONOINTMENT15
0713-0682-15Gentamicin Sulfate15 g in 1 TUBEOINTMENT155
0713-0682-31Gentamicin Sulfate30 g in 1 TUBEOINTMENT305
0713-0682-31Gentamicin Sulfate1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0682-15GM - Gram0713-0682d2b3555a-11dd-4f0c-ad17-5e06935a7fd812018-04-19
0713-0682-31GM - Gram0713-0682aeef44d1-aef8-4b1d-aaa8-97a4920439c312018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0682GENTAMICIN SULFATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20231123_16474069-510b-0754-9d78-9bc0354f6549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310465gentamicin sulfate 0.1 % Topical OintmentPSN16474069-510b-0754-9d78-9bc0354f65495
310465gentamicin 0.001 MG/MG Topical OintmentSCD16474069-510b-0754-9d78-9bc0354f65495
310465gentamicin (as gentamicin sulfate) 0.1 % Topical OintmentSY16474069-510b-0754-9d78-9bc0354f65495
310465gentamicin sulfate 0.001 MG/MG Topical OintmentSY16474069-510b-0754-9d78-9bc0354f65495
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
0713-0682-15007130682151 TUBE in 1 CARTON (0713-0682-15) / 15 g in 1 TUBE1 tube2017-12-210000-00-00NoNoCurrent
0713-0682-31007130682311 TUBE in 1 CARTON (0713-0682-31) / 30 g in 1 TUBE1 tube2017-12-210000-00-00NoNoCurrent