FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE

Product NDC
59651-691
11-digit product format
596510691
Labeler code
59651
Product ID
59651-691_8d142533-4e87-4030-8fe9-4fc7473b0442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-691-01LOPERAMIDE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
59651-691-05LOPERAMIDE HYDROCHLORIDE500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-691-01EA - Each59651-691ed907821-7363-4293-ba3a-0c302b484fe312024-02-14
59651-691-05EA - Each59651-69177af4ca0-20db-4c0b-b4ea-7d8a529e2f3312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-691LOPERAMIDE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230913_8d142533-4e87-4030-8fe9-4fc7473b0442.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3fdfc0e5-56a2-48a0-8ee6-390a194a29f35
978006loperamide HCl 2 MG Oral CapsulePSNd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b5
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fdfc0e5-56a2-48a0-8ee6-390a194a29f35
978006loperamide hydrochloride 2 MG Oral CapsuleSCDd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b5
978006loperamide HCl 2 MG Oral CapsulePSN3b0ac1a9-ffa6-9af6-e063-6294a90a26783
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3b0ac1a9-ffa6-9af6-e063-6294a90a26783
978006loperamide HCl 2 MG Oral CapsulePSN1adb7a28-9dc6-3f8b-e063-6394a90a93352
978006loperamide HCl 2 MG Oral CapsulePSN1be585e2-ef49-4210-8a2d-22a326e4cc1b2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1adb7a28-9dc6-3f8b-e063-6394a90a93352
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1be585e2-ef49-4210-8a2d-22a326e4cc1b2
978006loperamide HCl 2 MG Oral CapsulePSN518bb0f0-88f2-1c95-e063-6294a90a722f1
978006loperamide HCl 2 MG Oral CapsulePSN86d94804-ad01-4106-8f23-033f3a6bab9e1
978006loperamide HCl 2 MG Oral CapsulePSN8d142533-4e87-4030-8fe9-4fc7473b04421
978006loperamide hydrochloride 2 MG Oral CapsuleSCD518bb0f0-88f2-1c95-e063-6294a90a722f1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD86d94804-ad01-4106-8f23-033f3a6bab9e1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD8d142533-4e87-4030-8fe9-4fc7473b04421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-691-0159651069101100 CAPSULE in 1 BOTTLE (59651-691-01) 100 capsule2023-09-05NoNoCurrent
59651-691-0559651069105500 CAPSULE in 1 BOTTLE (59651-691-05) 500 capsule2023-09-05NoNoCurrent