FDA.reportPublic FDA data

loperamide hydrochloride

Product NDC
0904-6836
11-digit product format
009046836
Labeler code
0904
Product ID
0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-11-29
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
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 HYDROCHLORIDE1 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui1250685

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6836-20loperamide hydrochloride120 mL in 1 BOTTLESOLUTION1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6836-20ML - Milliliter0904-6836fd8396f5-01b5-48dd-8016-7dc263673e7d12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6836LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 1 package rows20250417_cf5dc855-f0cc-4d7e-8d15-472f7e654409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN0b1f8d41-51b3-4362-8de7-46bca5caff126
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD0b1f8d41-51b3-4362-8de7-46bca5caff126
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY0b1f8d41-51b3-4362-8de7-46bca5caff126
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY0b1f8d41-51b3-4362-8de7-46bca5caff126
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNcf5dc855-f0cc-4d7e-8d15-472f7e6544095
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDcf5dc855-f0cc-4d7e-8d15-472f7e6544095
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYcf5dc855-f0cc-4d7e-8d15-472f7e6544095
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYcf5dc855-f0cc-4d7e-8d15-472f7e6544095
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN7030f4ed-3cd1-428e-9cae-3b14933d41f54
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD7030f4ed-3cd1-428e-9cae-3b14933d41f54
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY7030f4ed-3cd1-428e-9cae-3b14933d41f54
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY7030f4ed-3cd1-428e-9cae-3b14933d41f54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6836-2000904683620120 mL in 1 BOTTLE (0904-6836-20) 120 ml2018-11-290000-00-00NoNoCurrent