FDA.reportPublic FDA data

MEDIQUE Diamode

Product NDC
85766-120
11-digit product format
857660120
Labeler code
85766
Product ID
85766-120_503225c0-98ca-4e90-e063-6394a90af07d
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA074091
Marketing category
ANDA
Marketing start
2008-12-30
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEDIQUE Diamode
Listing expiration
2027-12-31

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
85766-120-01MEDIQUE Diamode1 in 1 PACKETTABLET12
85766-120-06MEDIQUE Diamode6 in 1 BOX, UNIT-DOSETABLET62
85766-120-06MEDIQUE Diamode1 in 1 PACKETTABLET12
85766-120-24MEDIQUE Diamode24 in 1 BOX, UNIT-DOSETABLET242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978012Diamode 2 MG Oral TabletPSNac674e5a-94df-4a35-9854-4e66cc17e5092
978010loperamide HCl 2 MG Oral TabletPSNac674e5a-94df-4a35-9854-4e66cc17e5092
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBDac674e5a-94df-4a35-9854-4e66cc17e5092
978010loperamide hydrochloride 2 MG Oral TabletSCDac674e5a-94df-4a35-9854-4e66cc17e5092
978012Diamode 2 MG Oral TabletSYac674e5a-94df-4a35-9854-4e66cc17e5092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-120-01857660120011 TABLET in 1 PACKET (85766-120-01) 1 tablet2025-12-12NoNoHistorical
85766-120-06857660120066 PACKET in 1 BOX, UNIT-DOSE (85766-120-06) / 1 TABLET in 1 PACKET6 packet2025-12-12NoNoHistorical
85766-120-248576601202424 PACKET in 1 BOX, UNIT-DOSE (85766-120-24) / 1 TABLET in 1 PACKET (85766-120-01) 24 packet2025-12-12NoNoHistorical