FDA.reportPublic FDA data

MEDIQUE Diamode

Product NDC
47682-400
11-digit product format
476820400
Labeler code
47682
Product ID
47682-400_441e7620-28e5-8cc5-e063-6394a90a2a72
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
ANDA074091
Marketing category
ANDA
Marketing start
2025-12-01
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
MEDIQUE Diamode
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010, 978012

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
47682-400-46MEDIQUE Diamode1 in 1 PACKETTABLET122
47682-400-64MEDIQUE Diamode24 in 1 BOX, UNIT-DOSETABLET2422
47682-400-69MEDIQUE Diamode6 in 1 BOX, UNIT-DOSETABLET622

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978012Diamode 2 MG Oral TabletPSN069e7979-a223-4819-b6cf-ea2731bf156b22
978010loperamide HCl 2 MG Oral TabletPSN069e7979-a223-4819-b6cf-ea2731bf156b22
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBD069e7979-a223-4819-b6cf-ea2731bf156b22
978010loperamide hydrochloride 2 MG Oral TabletSCD069e7979-a223-4819-b6cf-ea2731bf156b22
978012Diamode 2 MG Oral TabletSY069e7979-a223-4819-b6cf-ea2731bf156b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
47682-400-46476820400461 TABLET in 1 PACKET (47682-400-46) 1 tablet2025-12-01NoNoCurrent
47682-400-644768204006424 PACKET in 1 BOX, UNIT-DOSE (47682-400-64) / 1 TABLET in 1 PACKET (47682-400-46) 24 packet2025-12-01NoNoCurrent
47682-400-69476820400696 PACKET in 1 BOX, UNIT-DOSE (47682-400-69) / 1 TABLET in 1 PACKET (47682-400-46) 6 packet2025-12-01NoNoCurrent