FDA.reportPublic FDA data

Altabax

Product NDC
21695-644
11-digit product format
216950644
Labeler code
21695
Product ID
21695-644_5da8f60f-c809-4161-a802-6fe823d532bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
retapamulin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
NDA022055
Marketing category
NDA
Marketing start
2010-01-07
Marketing end
0000-00-00
Substance
RETAPAMULIN
Active strength
10 mg/g
Pharmacologic classes
Diterpenes [CS],Pleuromutilin Antibacterial [EPC]
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
3896e7ae-97d6-492a-8634-7458a385550dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-644-102019-09-24C16284748780-1934fe258-49b0-48b1-e053-8cdaa90a720a5da8f60f-c809-4161-a802-6fe823d532bb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-644-10Altabax10 g in 1 TUBEOINTMENT101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-644-10GM - Gram21695-6442455981f-abc3-4e1f-bb96-6ee30528901312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RETAPAMULINACTIVE INGREDIENT4MG6O8991RALTABAX (RETAPAMULIN) OINTMENT [REBEL DISTRIBUTORS CORP.]1
RETAPAMULINACTIVE MOIETY4MG6O8991RALTABAX (RETAPAMULIN) OINTMENT [REBEL DISTRIBUTORS CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UALTABAX (RETAPAMULIN) OINTMENT [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-644ALTABAX (RETAPAMULIN) OINTMENT [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100907_5da8f60f-c809-4161-a802-6fe823d532bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
704858ALTABAX 1 % Topical OintmentPSN5da8f60f-c809-4161-a802-6fe823d532bb1
704855retapamulin 1 % Topical OintmentPSN5da8f60f-c809-4161-a802-6fe823d532bb1
704858retapamulin 0.01 MG/MG Topical Ointment [Altabax]SBD5da8f60f-c809-4161-a802-6fe823d532bb1
704855retapamulin 0.01 MG/MG Topical OintmentSCD5da8f60f-c809-4161-a802-6fe823d532bb1
704858Altabax 0.01 MG/MG Topical OintmentSY5da8f60f-c809-4161-a802-6fe823d532bb1
704858Altabax 1 % Topical OintmentSY5da8f60f-c809-4161-a802-6fe823d532bb1
704858Altabax 10 MG per GM Topical OintmentSY5da8f60f-c809-4161-a802-6fe823d532bb1
704855retapamulin 1 % Topical OintmentSY5da8f60f-c809-4161-a802-6fe823d532bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-644-102169506441010 g in 1 TUBE10 gHistorical