Anti-Diarrheal

Product NDC
57896-381
11-digit product format
578960381
Labeler code
57896
Product ID
57896-381_37510ed6-1ec9-14e2-e063-6394a90a2609
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
ANDA076497
Marketing category
ANDA
Marketing start
2006-01-01
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
Rxcui978010

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
57896-381-13Anti-Diarrheal2 in 1 CARTONTABLET27
57896-381-13Anti-Diarrheal6 in 1 BLISTER PACKTABLET67
57896-381-25Anti-Diarrheal6 in 1 BLISTER PACKTABLET67
57896-381-25Anti-Diarrheal4 in 1 CARTONTABLET47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-381-12EA - Each57896-381b8e1e77a-a057-4cdc-aabe-0c08ef7a3a3512018-04-19
57896-381-13EA - Each57896-3816de128ee-ca49-40ab-bf6f-0099f7afc3ea12022-03-09
57896-381-24EA - Each57896-381564ffe4d-6390-4563-b3ab-22b82d71dbdf12013-06-04
57896-381-25EA - Each57896-381caeb2e78-e036-4961-bb90-c907fd5ef8d012022-03-09
57896-381-96EA - Each57896-38125449e42-7e92-49f5-b5db-ac40c01a389812017-03-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-381ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 4 package rows20231020_0ecca2cd-c971-47b2-a2ac-ae7842dd4264.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN0ecca2cd-c971-47b2-a2ac-ae7842dd42647
978010loperamide hydrochloride 2 MG Oral TabletSCD0ecca2cd-c971-47b2-a2ac-ae7842dd42647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-381-125789603811212 TABLET in 1 BOTTLE (57896-381-12) 12 tablet2006-02-010000-00-00NoNoCurrent
57896-381-13578960381132 BLISTER PACK in 1 CARTON (57896-381-13) / 6 TABLET in 1 BLISTER PACK2 blister pack2021-03-010000-00-00NoNoCurrent
57896-381-245789603812424 TABLET in 1 BOTTLE (57896-381-24) 24 tablet2006-02-010000-00-00NoNoCurrent
57896-381-25578960381254 BLISTER PACK in 1 CARTON (57896-381-25) / 6 TABLET in 1 BLISTER PACK4 blister pack2020-09-010000-00-00NoNoCurrent
57896-381-485789603814848 TABLET in 1 BOTTLE (57896-381-48) 48 tablet2006-02-010000-00-00NoNoCurrent
57896-381-965789603819696 TABLET in 1 BOTTLE (57896-381-96) 96 tablet2006-02-010000-00-00NoNoCurrent