Gentamicin Sulfate

Product NDC
55045-1147
11-digit product format
550451147
Labeler code
55045
Product ID
55045-1147_cca757b4-55c2-4d0f-b578-e4d658c6db2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA062531
Marketing category
ANDA
Marketing start
1984-07-05
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
1 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
55045-1147-52019-11-27C16284748780-19855d018-d334-cd31-e053-dbdaa90ab51aGENTAMICIN SULFATE CREAM USP, 0.1% - gentamicin sulfate cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-1147-5Gentamicin Sulfate15 g in 1 TUBECREAM153

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-1147GENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 1 package rows20121003_e673c84f-d3cc-4e61-bdc7-5679cde9f359.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSNe673c84f-d3cc-4e61-bdc7-5679cde9f3593
197735gentamicin 1 MG/ML Topical CreamSCDe673c84f-d3cc-4e61-bdc7-5679cde9f3593
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSYe673c84f-d3cc-4e61-bdc7-5679cde9f3593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-1147-55504511470515 g in 1 TUBE15 gHistorical