FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
51660-123
11-digit product format
516600123
Labeler code
51660
Product ID
51660-123_0ea718d4-6b42-b9ee-e063-6294a90a8111
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA074091
Marketing category
ANDA
Marketing start
1993-02-01
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
Loperamide Hydrochloride
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
51660-123-06Loperamide Hydrochloride1 in 1 CARTONTABLET17
51660-123-06Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET67
51660-123-12Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET67
51660-123-12Loperamide Hydrochloride2 in 1 CARTONTABLET27
51660-123-24Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET67
51660-123-24Loperamide Hydrochloride4 in 1 CARTONTABLET47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-123-12EA - Each51660-123b916161a-9959-414f-96eb-fcc0281f28fa12013-07-02
51660-123-24EA - Each51660-12379d0070a-237a-4bd7-a5fa-d9355aef949a12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
TRISTEARININACTIVE INGREDIENTP6OCJ2551RLOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]2
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TRISTEARININACTIVE INGREDIENTP6OCJ2551RLOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
TRISTEARININACTIVE INGREDIENTP6OCJ2551RLOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-123LOPERAMIDE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]7Current NDC, Legacy NDC, 6 package rows20240112_c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNc26c15a1-3a8a-4562-8c5e-ebbc8b81e0c67
978010loperamide hydrochloride 2 MG Oral TabletSCDc26c15a1-3a8a-4562-8c5e-ebbc8b81e0c67
978010loperamide HCl 2 MG Oral TabletPSN82e65393-25b7-4114-9c71-5840ee8bad846
978010loperamide hydrochloride 2 MG Oral TabletSCD82e65393-25b7-4114-9c71-5840ee8bad846
978010loperamide HCl 2 MG Oral TabletPSN20462328-9b30-d882-e063-6394a90ae62b1
978010loperamide HCl 2 MG Oral TabletPSN812d636c-82d5-4eef-b154-cdf0659431221
978010loperamide HCl 2 MG Oral TabletPSNeb93a17e-7daf-4a9e-94a1-442039a383bd1
978010loperamide hydrochloride 2 MG Oral TabletSCD20462328-9b30-d882-e063-6394a90ae62b1
978010loperamide hydrochloride 2 MG Oral TabletSCD812d636c-82d5-4eef-b154-cdf0659431221
978010loperamide hydrochloride 2 MG Oral TabletSCDeb93a17e-7daf-4a9e-94a1-442039a383bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-123-06516600123061 BLISTER PACK in 1 CARTON (51660-123-06) / 6 TABLET in 1 BLISTER PACK1 blister pack1993-02-010000-00-00NoNoCurrent
51660-123-12516600123122 BLISTER PACK in 1 CARTON (51660-123-12) / 6 TABLET in 1 BLISTER PACK2 blister pack1993-02-010000-00-00NoNoCurrent
51660-123-24516600123244 BLISTER PACK in 1 CARTON (51660-123-24) / 6 TABLET in 1 BLISTER PACK4 blister pack1993-02-010000-00-00NoNoCurrent