FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
69230-325
11-digit product format
692300325
Labeler code
69230
Product ID
69230-325_e875c38b-493f-1f9f-e053-2995a90a6cd1
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA211438
Marketing category
ANDA
Marketing start
2021-06-17
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
Loperamide Hydrochloride and Simethicone
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
69230-325-04Loperamide Hydrochloride and Simethicone4 in 1 BLISTER PACKTABLET43
69230-325-04Loperamide Hydrochloride and Simethicone1 in 1 CARTONTABLET13
69230-325-06Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-06Loperamide Hydrochloride and Simethicone1 in 1 CARTONTABLET13
69230-325-08Loperamide Hydrochloride and Simethicone4 in 1 BLISTER PACKTABLET43
69230-325-08Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23
69230-325-12Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-12Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23
69230-325-18Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-18Loperamide Hydrochloride and Simethicone3 in 1 CARTONTABLET33
69230-325-24Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET43
69230-325-24Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-325-12EA - Each69230-32522efe18e-340c-4822-ac6b-7106f3c2dad112021-10-08
69230-325-24EA - Each69230-325beeb7395-3a5f-4743-b07a-ba5073b45b2012021-10-08
69230-325-32EA - Each69230-325a5d2c93e-f48c-4327-b177-03eef10a11a712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-325LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE) TABLET [CAMBER CONSUMER CARE INC]3Current NDC, Legacy NDC, 12 package rows20220913_e2a4af66-1d05-408c-9f11-f2a9f325d75c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNe2a4af66-1d05-408c-9f11-f2a9f325d75c3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDe2a4af66-1d05-408c-9f11-f2a9f325d75c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-325-006923003250010 POUCH in 1 DRUM (69230-325-00) / 1000 TABLET in 1 POUCH10 pouch17-JUN-21Current
69230-325-04692300325041 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK1 blister pack2021-06-170000-00-00NoNoCurrent
69230-325-06692300325061 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK1 blister pack2021-06-170000-00-00NoNoCurrent
69230-325-08692300325082 BLISTER PACK in 1 CARTON (69230-325-08) / 4 TABLET in 1 BLISTER PACK2 blister pack2021-06-170000-00-00NoNoCurrent
69230-325-12692300325122 BLISTER PACK in 1 CARTON (69230-325-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2021-06-170000-00-00NoNoCurrent
69230-325-18692300325183 BLISTER PACK in 1 CARTON (69230-325-18) / 6 TABLET in 1 BLISTER PACK3 blister pack2021-06-170000-00-00NoNoCurrent
69230-325-24692300325244 BLISTER PACK in 1 CARTON (69230-325-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2021-06-170000-00-00NoNoCurrent