Loperamide Hydrochloride

Product NDC
51407-999
11-digit product format
514070999
Labeler code
51407
Product ID
51407-999_4b95d0cc-99d4-903e-e063-6394a90a26ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA215001
Marketing category
ANDA
Marketing start
2021-10-06
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loperamide Hydrochloride
Listing expiration
2027-12-31

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
51407-999-01Loperamide Hydrochloride100 in 1 BOTTLECAPSULE1003
51407-999-05Loperamide Hydrochloride500 in 1 BOTTLECAPSULE5003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN396f7e13-b357-52be-e063-6394a90a92fc3
978006loperamide hydrochloride 2 MG Oral CapsuleSCD396f7e13-b357-52be-e063-6394a90a92fc3
978006loperamide HCl 2 MG Oral CapsulePSN3f031dfb-be55-5a44-e063-6394a90aeec51
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3f031dfb-be55-5a44-e063-6394a90aeec51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-999-0151407099901100 CAPSULE in 1 BOTTLE (51407-999-01) 100 capsule2025-07-07NoNoCurrent
51407-999-0551407099905500 CAPSULE in 1 BOTTLE (51407-999-05) 500 capsule2025-07-07NoNoCurrent