Handy Solutions Anti-Diarrheal

Product NDC
67751-162
11-digit product format
677510162
Labeler code
67751
Product ID
67751-162_f6f79fd3-55a5-4d2a-e053-6394a90a4ddd
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
ANDA074091
Marketing category
ANDA
Marketing start
2016-09-21
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
Handy Solutions Anti-Diarrheal
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-162-012023-03-15C16284748780-1f386c64a-201c-0266-e053-dadaa90a7c1aHandy Solutions Anti-Diarrheal
67751-162-012023-01-30C16284748780-1f386c64a-201c-0266-e053-dadaa90a7c1aHandy Solutions Anti-Diarrheal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-162-01Handy Solutions Anti-Diarrheal1 in 1 POUCHTABLET13
67751-162-01Handy Solutions Anti-Diarrheal1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-162HANDY SOLUTIONS ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 2 package rows20230316_76e32e66-4af5-47a5-83ff-cbba206975d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN76e32e66-4af5-47a5-83ff-cbba206975d63
978010loperamide hydrochloride 2 MG Oral TabletSCD76e32e66-4af5-47a5-83ff-cbba206975d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-162-01677510162011 POUCH in 1 CARTON (67751-162-01) / 1 TABLET in 1 POUCH1 pouch2016-09-210000-00-00NoNoCurrent