LOPERAMIDE HYDROCHLORIDE

Product NDC
67296-2172
11-digit product format
672962172
Labeler code
67296
Product ID
67296-2172_44f72085-ac64-5dc5-e063-6394a90a0ff0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA218122
Marketing category
ANDA
Marketing start
2023-09-05
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
Rxcui978006

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
67296-2172-1LOPERAMIDE HYDROCHLORIDE15 in 1 BOTTLECAPSULE153

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3b0ac1a9-ffa6-9af6-e063-6294a90a26783
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3b0ac1a9-ffa6-9af6-e063-6294a90a26783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2172-16729621720115 CAPSULE in 1 BOTTLE (67296-2172-1) 15 capsule2023-09-05NoNoCurrent