FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
50090-0460
11-digit product format
500900460
Labeler code
50090
Product ID
50090-0460_758f74d5-c515-43e7-b4be-2b07007ac83e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA073192
Marketing category
ANDA
Marketing start
1993-05-01
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
Rxcui978006

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
50090-0460-02023-02-06C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only
50090-0460-32023-02-06C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only
50090-0460-42023-02-06C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only
50090-0460-02023-01-30C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only
50090-0460-32023-01-30C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only
50090-0460-42023-01-30C16284748780-1f386c64a-3936-0266-e053-dadaa90a7c1aLoperamide Hydrochloride Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0460-0Loperamide Hydrochloride15 in 1 BOTTLECAPSULE1513
50090-0460-3Loperamide Hydrochloride12 in 1 BOTTLECAPSULE1213
50090-0460-4Loperamide Hydrochloride30 in 1 BOTTLECAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0460-0EA - Each50090-046063a445ed-0b6d-498f-9627-123514fb075c12018-09-05
50090-0460-3EA - Each50090-04609dcee5ac-a9ba-497a-913e-3d9c54bc4c2512018-09-05
50090-0460-4EA - Each50090-0460d6040478-4b95-493e-bd9f-d15dfe59925512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0460LOPERAMIDE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20230208_97c37571-9116-40d6-ba07-f4a5a8d9b689.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN97c37571-9116-40d6-ba07-f4a5a8d9b68913
978006loperamide hydrochloride 2 MG Oral CapsuleSCD97c37571-9116-40d6-ba07-f4a5a8d9b68913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0460-05009004600015 CAPSULE in 1 BOTTLE (50090-0460-0) 15 capsule2016-06-290000-00-00NoNoCurrent
50090-0460-35009004600312 CAPSULE in 1 BOTTLE (50090-0460-3) 12 capsule2016-06-290000-00-00NoNoCurrent
50090-0460-45009004600430 CAPSULE in 1 BOTTLE (50090-0460-4) 30 capsule2016-06-290000-00-00NoNoCurrent