FDA.reportPublic FDA data

GENTAMICIN SULFATE

Product NDC
51662-1597
11-digit product format
516621597
Labeler code
51662
Product ID
51662-1597_0ff9b5b7-53ad-15f6-e063-6394a90a82aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GENTAMICIN SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA062420
Marketing category
ANDA
Marketing start
2022-10-01
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
51662-1597-2GENTAMICIN SULFATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22
51662-1597-2GENTAMICIN SULFATE1 in 1 POUCHINJECTION, SOLUTION12
51662-1597-3GENTAMICIN SULFATE25 in 1 CASEINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1597GENTAMICIN SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240524_e9fbe619-2afe-f1d7-e053-2a95a90aab29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870650gentamicin sulfate 80 MG in 2 ML InjectionPSNe9fbe619-2afe-f1d7-e053-2a95a90aab292
18706502 ML gentamicin 40 MG/ML InjectionSCDe9fbe619-2afe-f1d7-e053-2a95a90aab292
1870650gentamicin (as gentamicin sulfate) 80 MG per 2 ML InjectionSYe9fbe619-2afe-f1d7-e053-2a95a90aab292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1597-2516621597022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
51662-1597-35166215970325 POUCH in 1 CASE (51662-1597-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1597-2) / 2 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-10-010000-00-00NoNoCurrent