ACARBOSE

Product NDC
11788-041
11-digit product format
117880041
Labeler code
11788
Product ID
11788-041_ae9f2dbb-1c10-c5d7-e053-2a95a90a78c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACARBOSE
Dosage form
TABLET
Route
ORAL
Labeler
Aiping Pharmaceutical
Application
ANDA213821
Marketing category
ANDA
Marketing start
2020-09-30
Marketing end
0000-00-00
Substance
ACARBOSE
Active strength
100 mg/1
Pharmacologic classes
alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2712f130-8721-1a9d-6846-53893b13fb67Product name220210312

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11788-041-012022-01-28C16284748780-1d6a99b39-e2a0-a426-e053-dadaa90af4c2Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-041-01ACARBOSE100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11788-041ACARBOSE TABLET [AIPING PHARMACEUTICAL]1Legacy NDC, 1 package rows20200930_c445953d-c20a-4b70-8173-009bffc5777b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199150acarbose 100 MG Oral TabletPSNc445953d-c20a-4b70-8173-009bffc5777b1
200132acarbose 25 MG Oral TabletPSNc445953d-c20a-4b70-8173-009bffc5777b1
199149acarbose 50 MG Oral TabletPSNc445953d-c20a-4b70-8173-009bffc5777b1
199150acarbose 100 MG Oral TabletSCDc445953d-c20a-4b70-8173-009bffc5777b1
200132acarbose 25 MG Oral TabletSCDc445953d-c20a-4b70-8173-009bffc5777b1
199149acarbose 50 MG Oral TabletSCDc445953d-c20a-4b70-8173-009bffc5777b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11788-041-0111788004101100 TABLET in 1 BOTTLE (11788-041-01) 100 tablet2020-09-300000-00-00NoNoCurrent