equate diarrhea control

Product NDC
49035-695
11-digit product format
490350695
Labeler code
49035
Product ID
49035-695_0e65f9fd-3921-4b26-be5d-8f55c2ba48a0
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091292
Marketing category
ANDA
Marketing start
2020-09-03
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
equate diarrhea control
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-695-26equate diarrhea control118 mL in 1 BOTTLESUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-695EQUATE DIARRHEA CONTROL (LOPERAMIDE HCL) SUSPENSION [WAL-MART STORES INC]2Current NDC, Legacy NDC, 1 package rows20200916_53283496-4e65-40ea-8dfb-851ea2c0cc15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN53283496-4e65-40ea-8dfb-851ea2c0cc153
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD53283496-4e65-40ea-8dfb-851ea2c0cc153
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY53283496-4e65-40ea-8dfb-851ea2c0cc153
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY53283496-4e65-40ea-8dfb-851ea2c0cc153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-695-2649035069526118 mL in 1 BOTTLE (49035-695-26) 118 ml2020-09-030000-00-00NoNoCurrent