FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
52565-085
11-digit product format
525650085
Labeler code
52565
Product ID
52565-085_88cf4850-8a42-45a1-a66e-698795db7d10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209304
Marketing category
ANDA
Marketing start
2019-10-18
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

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-1874a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209304-001GENTAMICIN SULFATEEQ 0.1% BASECREAM / TOPICALAT2019-10-183f01610625f2…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209304-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209304-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A209304-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209304-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209304-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209304-001AT13f01610625f2…

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
52565-085-152022-01-28C16284748780-1d6a99b39-3660-a426-e053-dadaa90af4c2GENTAMICIN SULFATE CREAM USP, 0.1%
52565-085-302022-01-28C16284748780-1d6a99b39-3660-a426-e053-dadaa90af4c2GENTAMICIN SULFATE CREAM USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-085-15Gentamicin Sulfate1 in 1 CARTONCREAM11
52565-085-15Gentamicin Sulfate15 g in 1 TUBECREAM151
52565-085-30Gentamicin Sulfate1 in 1 CARTONCREAM11
52565-085-30Gentamicin Sulfate30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-085-15GM - Gram52565-085ce16ad66-1fee-4015-a60f-12f154682e6512019-12-10
52565-085-30GM - Gram52565-0856d00da5e-71e1-4f7e-9d1d-79965d327cb812019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-085GENTAMICIN SULFATE CREAM [TELIGENT PHARMA, INC.]1Legacy NDC, 4 package rows20191022_c08321a0-4961-9d3b-8e17-728470f5d653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSNc08321a0-4961-9d3b-8e17-728470f5d6531
197735gentamicin 1 MG/ML Topical CreamSCDc08321a0-4961-9d3b-8e17-728470f5d6531
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSYc08321a0-4961-9d3b-8e17-728470f5d6531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-085-15525650085151 TUBE in 1 CARTON (52565-085-15) > 15 g in 1 TUBE1 tube2019-10-180000-00-00NoNoCurrent
52565-085-30525650085301 TUBE in 1 CARTON (52565-085-30) > 30 g in 1 TUBE1 tube2019-10-180000-00-00NoNoCurrent