FDA.reportPublic FDA data

Loperamide hydrochloride

Product NDC
70771-1769
11-digit product format
707711769
Labeler code
70771
Product ID
70771-1769_b43ff8ed-7175-4a7a-8e42-5c66324b495c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA217471
Marketing category
ANDA
Marketing start
2023-06-25
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
70771-1769-1Loperamide hydrochloride100 in 1 BOTTLECAPSULE1001
70771-1769-2Loperamide hydrochloride10 in 1 BLISTER PACKCAPSULE101
70771-1769-4Loperamide hydrochloride10 in 1 CARTONCAPSULE101
70771-1769-5Loperamide hydrochloride500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1769LOPERAMIDE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 4 package rows20230625_5d13405c-8fd7-454f-9b49-3d8b9ef672b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN5d13405c-8fd7-454f-9b49-3d8b9ef672b81
978006loperamide hydrochloride 2 MG Oral CapsuleSCD5d13405c-8fd7-454f-9b49-3d8b9ef672b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1769-170771176901100 CAPSULE in 1 BOTTLE (70771-1769-1) 100 capsule2023-06-25NoNoHistorical
70771-1769-27077117690210 in 1 BLISTER PACKHistorical
70771-1769-47077117690410 BLISTER PACK in 1 CARTON (70771-1769-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1769-2) 10 blister pack2023-06-25NoNoHistorical
70771-1769-570771176905500 CAPSULE in 1 BOTTLE (70771-1769-5) 500 capsule2023-06-25NoNoHistorical