FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
0404-9865
11-digit product format
004049865
Labeler code
0404
Product ID
0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA062420
Marketing category
ANDA
Marketing start
2022-01-10
Substance
GENTAMICIN SULFATE
Active strength
40 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 SULFATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui1870650

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
0404-9865-02Gentamicin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
0404-9865-02Gentamicin Sulfate1 in 1 BAGINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9865GENTAMICIN SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240711_913a36c3-50d6-429a-a8dd-a03126d2ca08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870650gentamicin sulfate 80 MG in 2 ML InjectionPSN913a36c3-50d6-429a-a8dd-a03126d2ca085
18706502 ML gentamicin 40 MG/ML InjectionSCD913a36c3-50d6-429a-a8dd-a03126d2ca085
1870650gentamicin (as gentamicin sulfate) 80 MG per 2 ML InjectionSY913a36c3-50d6-429a-a8dd-a03126d2ca085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9865-02004049865021 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02) / 2 mL in 1 VIAL, SINGLE-DOSE2022-01-100000-00-00NoNoCurrent