FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
52565-090
11-digit product format
525650090
Labeler code
52565
Product ID
52565-090_bab39bb1-5c1b-498e-889a-18915032086b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209233
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
1 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-090-152023-01-30C16284748780-1f386c649-a148-0266-e053-dadaa90a7c1aGentamicin Sulfate Ointment USP, 0.1%
52565-090-302023-01-30C16284748780-1f386c649-a148-0266-e053-dadaa90a7c1aGentamicin Sulfate Ointment USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-090-15Gentamicin Sulfate15 g in 1 TUBEOINTMENT152
52565-090-15Gentamicin Sulfate1 in 1 CARTONOINTMENT12
52565-090-30Gentamicin Sulfate1 in 1 CARTONOINTMENT12
52565-090-30Gentamicin Sulfate30 g in 1 TUBEOINTMENT302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-090-15GM - Gram52565-090ec698551-543a-4361-8fc8-860c87e3084912019-04-11
52565-090-30GM - Gram52565-0900ed738bb-f1ca-4fdd-932e-5d3fb269d90812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-090GENTAMICIN SULFATE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_e2fd1885-afad-dcc8-ad64-27d45f63c00f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310465gentamicin sulfate 0.1 % Topical OintmentPSNe2fd1885-afad-dcc8-ad64-27d45f63c00f2
310465gentamicin 0.001 MG/MG Topical OintmentSCDe2fd1885-afad-dcc8-ad64-27d45f63c00f2
310465gentamicin (as gentamicin sulfate) 0.1 % Topical OintmentSYe2fd1885-afad-dcc8-ad64-27d45f63c00f2
310465gentamicin sulfate 0.001 MG/MG Topical OintmentSYe2fd1885-afad-dcc8-ad64-27d45f63c00f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-090-15525650090151 TUBE in 1 CARTON (52565-090-15) > 15 g in 1 TUBE1 tube2018-12-310000-00-00NoNoCurrent
52565-090-30525650090301 TUBE in 1 CARTON (52565-090-30) > 30 g in 1 TUBE1 tube2018-12-310000-00-00NoNoCurrent