FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
0713-0683
11-digit product format
007130683
Labeler code
0713
Product ID
0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA064056
Marketing category
ANDA
Marketing start
2016-11-11
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
Rxcui197735

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
0713-0683-15Gentamicin Sulfate1 in 1 CARTONCREAM15
0713-0683-15Gentamicin Sulfate15 g in 1 TUBECREAM155
0713-0683-31Gentamicin Sulfate30 g in 1 TUBECREAM305
0713-0683-31Gentamicin Sulfate1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0683-15GM - Gram0713-068397942b5b-eb35-4f31-b99e-3e34fcc1165912017-03-06
0713-0683-31GM - Gram0713-06835b41e0d1-8044-4fbe-8687-7e2f1ea4e6ef12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0683GENTAMICIN SULFATE CREAM [COSETTE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20231123_9e550dc9-509e-da05-8a97-ecbd0f5dd633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSN9e550dc9-509e-da05-8a97-ecbd0f5dd6335
197735gentamicin 1 MG/ML Topical CreamSCD9e550dc9-509e-da05-8a97-ecbd0f5dd6335
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSY9e550dc9-509e-da05-8a97-ecbd0f5dd6335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0683-15007130683151 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE1 tube2016-11-110000-00-00NoNoCurrent
0713-0683-31007130683311 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE1 tube2016-11-110000-00-00NoNoCurrent