Anti-Diarrheal

Product NDC
37808-988
11-digit product format
378080988
Labeler code
37808
Product ID
37808-988_df62ad54-5aa3-4d05-e053-2a95a90aa48d
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HEB
Application
NDA021855
Marketing category
NDA
Marketing start
2018-12-04
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
Anti-Diarrheal
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
37808-988-12Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED23
37808-988-12Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-988ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HEB]3Current NDC, Legacy NDC, 2 package rows20220520_3ea49be2-1744-4d14-bc43-09d35fd4b3c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3ea49be2-1744-4d14-bc43-09d35fd4b3c73
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3ea49be2-1744-4d14-bc43-09d35fd4b3c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-988-12378080988122 BLISTER PACK in 1 CARTON (37808-988-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2018-12-040000-00-00NoNoCurrent