anti diarrheal

Product NDC
37808-449
11-digit product format
378080449
Labeler code
37808
Product ID
37808-449_80acab10-ff9e-4353-8bf0-a9ea6138e047
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-06-22
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
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
anti diarrheal
Listing expiration
2026-12-31

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
37808-449-34anti diarrheal240 mL in 1 BOTTLESOLUTION2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-449ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [H E B]3Current NDC, Legacy NDC, 1 package rows20250416_01964f8a-f05c-4f72-9530-e0cffd981ffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN01964f8a-f05c-4f72-9530-e0cffd981ffa3
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD01964f8a-f05c-4f72-9530-e0cffd981ffa3
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY01964f8a-f05c-4f72-9530-e0cffd981ffa3
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY01964f8a-f05c-4f72-9530-e0cffd981ffa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-449-3437808044934240 mL in 1 BOTTLE (37808-449-34) 240 ml2018-06-220000-00-00NoNoCurrent