Loperamide Hydrochloride

Product NDC
63941-123
11-digit product format
639410123
Labeler code
63941
Product ID
63941-123_0ea71b09-2bb9-8966-e063-6294a90a813e
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA074091
Marketing category
ANDA
Marketing start
1993-02-01
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

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
63941-123-12Loperamide Hydrochloride12 in 1 BLISTER PACKTABLET124
63941-123-24Loperamide Hydrochloride24 in 1 BLISTER PACKTABLET244

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-123LOPERAMIDE HYDROCHLORIDE TABLET [VALU MERCHANDISERS COMPANY]4Current NDC, Legacy NDC, 2 package rows20240112_33335063-49a9-4e08-9d77-4cd80e94f021.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN33335063-49a9-4e08-9d77-4cd80e94f0214
978010loperamide hydrochloride 2 MG Oral TabletSCD33335063-49a9-4e08-9d77-4cd80e94f0214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-123-126394101231212 TABLET in 1 BLISTER PACK (63941-123-12) 12 tablet1993-02-010000-00-00NoNoCurrent
63941-123-246394101232424 TABLET in 1 BLISTER PACK (63941-123-24) 24 tablet1993-02-010000-00-00NoNoCurrent