signature care anti diarrheal

Product NDC
21130-440
11-digit product format
211300440
Labeler code
21130
Product ID
21130-440_9d47bcef-ac34-445c-9e4d-3c091e5715a8
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Safeway
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-07-12
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
signature care 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-440-34signature care anti diarrheal240 mL in 1 BOTTLESOLUTION2402
21130-440-34signature care anti diarrheal1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-440SIGNATURE CARE ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [SAFEWAY]2Current NDC, Legacy NDC, 2 package rows20200520_f8c48a55-5626-438a-a80a-cf74b51b2598.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNf8c48a55-5626-438a-a80a-cf74b51b25982
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDf8c48a55-5626-438a-a80a-cf74b51b25982
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYf8c48a55-5626-438a-a80a-cf74b51b25982
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYf8c48a55-5626-438a-a80a-cf74b51b25982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-440-34211300440341 BOTTLE in 1 CARTON (21130-440-34) / 240 mL in 1 BOTTLE1 bottle2018-07-120000-00-00NoNoCurrent