Simethicone

Product NDC
51013-439
11-digit product format
510130439
Labeler code
51013
Product ID
51013-439_9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PURACAP PHARMACEUTICAL LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-25
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51013-439-022025-01-30C16284748780-12cef2736-74a7-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-439-02Simethicone1 in 1 CARTONCAPSULE, LIQUID FILLED11
51013-439-02Simethicone12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-439SIMETHICONE CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 2 package rows20190325_9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN9b4d1bff-55f1-4f86-a9dd-bcc7ad39e7631
412111simethicone 250 MG Oral CapsuleSCD9b4d1bff-55f1-4f86-a9dd-bcc7ad39e7631
412111dimethicone 250 MG Oral CapsuleSY9b4d1bff-55f1-4f86-a9dd-bcc7ad39e7631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-439-02510130439021 BLISTER PACK in 1 CARTON (51013-439-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-250000-00-00NoNoCurrent