FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
71872-7337
11-digit product format
718727337
Labeler code
71872
Product ID
71872-7337_3532c536-3b10-950e-e063-6294a90a51de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GENTAMICIN SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA062420
Marketing category
ANDA
Marketing start
2005-08-29
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
71872-7337-1Gentamicin Sulfate1 in 1 BAGINJECTION, SOLUTION11
71872-7337-1Gentamicin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7337GENTAMICIN SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20250519_3532bb39-a1a6-9d67-e063-6294a90abc0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870650gentamicin sulfate 80 MG in 2 ML InjectionPSN3532bb39-a1a6-9d67-e063-6294a90abc0c1
18706502 ML gentamicin 40 MG/ML InjectionSCD3532bb39-a1a6-9d67-e063-6294a90abc0c1
1870650gentamicin (as gentamicin sulfate) 80 MG per 2 ML InjectionSY3532bb39-a1a6-9d67-e063-6294a90abc0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7337-1718727337011 VIAL, SINGLE-DOSE in 1 BAG (71872-7337-1) / 2 mL in 1 VIAL, SINGLE-DOSE2024-12-10NoNoHistorical