Gentamicin Sulfate

Product NDC
71872-7216
11-digit product format
718727216
Labeler code
71872
Product ID
71872-7216_fad0da7e-68e5-c873-e053-6294a90a6fac
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
2015-12-09
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
71872-7216-1Gentamicin Sulfate1 in 1 BAGINJECTION, SOLUTION12
71872-7216-1Gentamicin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7216GENTAMICIN SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230504_a8b15217-cccb-2260-e053-2995a90a709d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870650gentamicin sulfate 80 MG in 2 ML InjectionPSNa8b15217-cccb-2260-e053-2995a90a709d2
18706502 ML gentamicin 40 MG/ML InjectionSCDa8b15217-cccb-2260-e053-2995a90a709d2
1870650gentamicin (as gentamicin sulfate) 80 MG per 2 ML InjectionSYa8b15217-cccb-2260-e053-2995a90a709d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7216-1718727216011 VIAL, SINGLE-DOSE in 1 BAG (71872-7216-1) / 2 mL in 1 VIAL, SINGLE-DOSE2020-06-220000-00-00NoNoCurrent