FDA.reportPublic FDA data

anti diarrheal and anti gas

Product NDC
0363-1830
11-digit product format
003631830
Labeler code
0363
Product ID
0363-1830_580f2635-1560-43cd-825a-9e930369f958
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-10
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125; 2 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
anti diarrheal and anti gas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 77TI35393C
Rxcui978001

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1830-53anti diarrheal and anti gas12 in 1 CARTONTABLET124
0363-1830-53anti diarrheal and anti gas1 in 1 BLISTER PACKTABLET14
0363-1830-62anti diarrheal and anti gas1 in 1 BLISTER PACKTABLET14
0363-1830-62anti diarrheal and anti gas24 in 1 CARTONTABLET244
0363-1830-65anti diarrheal and anti gas1 in 1 CARTONTABLET14
0363-1830-65anti diarrheal and anti gas30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1830-53EA - Each0363-1830405a7962-d4fb-45f7-bed8-ae51ee38427212022-06-06
0363-1830-62EA - Each0363-18306b582286-349c-4461-ba7b-9584ac1afd7312022-06-06
0363-1830-65EA - Each0363-183059994f93-e983-4384-8d48-a09d19c8b7a912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1830ANTI DIARRHEAL AND ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [WALGREEN COMPANY]4Current NDC, Legacy NDC, 6 package rows20240724_0999243a-c3be-41a6-b327-962e63d8c356.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN0999243a-c3be-41a6-b327-962e63d8c3564
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD0999243a-c3be-41a6-b327-962e63d8c3564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1830-530036318305312 BLISTER PACK in 1 CARTON (0363-1830-53) / 1 TABLET in 1 BLISTER PACK12 blister pack2018-10-100000-00-00NoNoCurrent
0363-1830-620036318306224 BLISTER PACK in 1 CARTON (0363-1830-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2019-06-250000-00-00NoNoCurrent
0363-1830-65003631830651 BOTTLE in 1 CARTON (0363-1830-65) > 30 TABLET in 1 BOTTLE1 bottle2018-10-100000-00-00NoNoCurrent