topcare anti diarrheal anti gas

Product NDC
36800-633
11-digit product format
368000633
Labeler code
36800
Product ID
36800-633_0bd10a98-0d1c-4ae7-b758-25916d54fae1
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-09
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active strength
2 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-633-53topcare anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
36800-633-53topcare anti diarrheal anti gas12 in 1 CARTONTABLET125
36800-633-62topcare anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
36800-633-62topcare anti diarrheal anti gas24 in 1 CARTONTABLET245
36800-633-65topcare anti diarrheal anti gas30 in 1 BOTTLETABLET305
36800-633-65topcare anti diarrheal anti gas1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-633TOPCARE ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [TOPCO ASSOCIATES LLC]5Legacy NDC, 6 package rows20240724_7ada1c47-8d4f-4742-9b6d-aa2766119532.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN7ada1c47-8d4f-4742-9b6d-aa27661195325
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD7ada1c47-8d4f-4742-9b6d-aa27661195325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-633-533680006335312 BLISTER PACK in 1 CARTON (36800-633-53) > 1 TABLET in 1 BLISTER PACK12 blister pack2018-10-090000-00-00NoNoCurrent
36800-633-623680006336224 BLISTER PACK in 1 CARTON (36800-633-62) > 1 TABLET in 1 BLISTER PACK24 blister pack2020-06-050000-00-00NoNoCurrent
36800-633-65368000633651 BOTTLE in 1 CARTON (36800-633-65) > 30 TABLET in 1 BOTTLE1 bottle2018-10-090000-00-00NoNoCurrent