FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
68094-129
11-digit product format
680940129
Labeler code
68094
Product ID
68094-129_73a0214b-3f58-4357-ab53-314111602166
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA091292
Marketing category
ANDA
Marketing start
2020-05-18
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
Loperamide Hydrochloride
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-129-59Loperamide Hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION154
68094-129-62Loperamide Hydrochloride3 in 1 CASESOLUTION34
68094-129-62Loperamide Hydrochloride10 in 1 TRAYSOLUTION104
68094-129-59Loperamide Hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION152
68094-129-62Loperamide Hydrochloride3 in 1 CASESOLUTION32
68094-129-62Loperamide Hydrochloride10 in 1 TRAYSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-129LOPERAMIDE HYDROCHLORIDE SOLUTION [PRECISION DOSE, INC.]2Current NDC, Legacy NDC, 3 package rows20230623_0d1eb0dc-991b-4e54-bae1-3660bddc6243.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY0d1eb0dc-991b-4e54-bae1-3660bddc62432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-129-596809401295915 mL in 1 CUP, UNIT-DOSE15 mlHistorical
68094-129-62680940129623 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59) 3 tray2020-05-180000-00-00NoNoCurrent