Anti-Diarrheal

Product NDC
49035-483
11-digit product format
490350483
Labeler code
49035
Product ID
49035-483_f0feada3-d253-2da9-e053-2a95a90a178e
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
NDA021855
Marketing category
NDA
Marketing start
2019-01-01
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
49035-483-12Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED23
49035-483-12Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-483-12EA - Each49035-483f0a42471-1224-49cd-824a-5cc4b331d72612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-483ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WAL-MART STORES, INC.]3Current NDC, Legacy NDC, 2 package rows20221230_507acd63-b2b4-465e-bb94-2d66724de20a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN507acd63-b2b4-465e-bb94-2d66724de20a3
978006loperamide hydrochloride 2 MG Oral CapsuleSCD507acd63-b2b4-465e-bb94-2d66724de20a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-483-12490350483122 BLISTER PACK in 1 CARTON (49035-483-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-01-010000-00-00NoNoCurrent