FDA.reportPublic FDA data

Gentamicin Sulfate Cream USP, 0.1%

Product NDC
63739-055
11-digit product format
637390055
Labeler code
63739
Product ID
63739-055_1e867efb-9004-4ab1-8070-ec7ea1bea6f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
McKesson Corporation
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
2022-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-055-65Gentamicin Sulfate Cream USP, 0.1%15 g in 1 TUBECREAM151
63739-055-65Gentamicin Sulfate Cream USP, 0.1%1 in 1 CARTONCREAM11
63739-055-66Gentamicin Sulfate Cream USP, 0.1%30 g in 1 TUBECREAM301
63739-055-66Gentamicin Sulfate Cream USP, 0.1%1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-055-65GM - Gram63739-05511d8cf89-44ac-400d-a9ba-fa3dcb858c2112021-10-08
63739-055-66GM - Gram63739-0558e46d6fd-feaa-42b1-9e64-37d313f0a4a412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-055GENTAMICIN SULFATE CREAM USP, 0.1% (GENTAMICIN SULFATE) CREAM [MCKESSON CORPORATION]1Legacy NDC, 4 package rows20210528_c302559f-9e0e-4c55-857c-8fda546d61f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSNc302559f-9e0e-4c55-857c-8fda546d61f01
197735gentamicin 1 MG/ML Topical CreamSCDc302559f-9e0e-4c55-857c-8fda546d61f01
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSYc302559f-9e0e-4c55-857c-8fda546d61f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-055-65637390055651 TUBE in 1 CARTON (63739-055-65) > 15 g in 1 TUBE1 tube2021-05-250000-00-00NoNoCurrent
63739-055-66637390055661 TUBE in 1 CARTON (63739-055-66) > 30 g in 1 TUBE1 tube2021-05-250000-00-00NoNoCurrent