Loperamide Hydrochloride

Product NDC
60687-229
11-digit product format
606870229
Labeler code
60687
Product ID
60687-229_437e8cc1-d818-dac5-e063-6294a90a1752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA073192
Marketing category
ANDA
Marketing start
2017-01-03
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
60687-229-01Loperamide Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE1008
60687-229-11Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-229-01EA - Each60687-2297464fae6-63da-48a3-b0cd-f6dec9f210d812017-03-06
60687-229-11EA - Each60687-2293a0eb886-67ab-46cc-9e15-f53e6b69216a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-229LOPERAMIDE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240220_42989f90-8ff5-44d1-a462-28c18ce02738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN42989f90-8ff5-44d1-a462-28c18ce027388
978006loperamide hydrochloride 2 MG Oral CapsuleSCD42989f90-8ff5-44d1-a462-28c18ce027388
978006loperamide HCl 2 MG Oral CapsulePSNca8de42f-8aea-4e35-ab3a-75ecea718f4f5
978006loperamide hydrochloride 2 MG Oral CapsuleSCDca8de42f-8aea-4e35-ab3a-75ecea718f4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-229-0160687022901100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-229-01) / 1 CAPSULE in 1 BLISTER PACK (60687-229-11) 100 blister pack2017-01-030000-00-00NoNoCurrent
60687-229-11606870229111 in 1 BLISTER PACKHistorical