FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
0378-2100
11-digit product format
003782100
Labeler code
0378
Product ID
0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA072741
Marketing category
ANDA
Marketing start
1991-09-18
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
Rxcui978006

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
0378-2100-01Loperamide Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10014
0378-2100-05Loperamide Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE50014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2100LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20240111_72a7ae47-cdf3-4949-b9f8-f29b153f787f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNf092b8a5-80b0-40ba-af45-2ac9edaa7704103
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf092b8a5-80b0-40ba-af45-2ac9edaa7704103
978006loperamide HCl 2 MG Oral CapsulePSNad71d4ab-d293-47a2-8f3f-2c9f42d76e4017
978006loperamide hydrochloride 2 MG Oral CapsuleSCDad71d4ab-d293-47a2-8f3f-2c9f42d76e4017
978006loperamide HCl 2 MG Oral CapsulePSN72a7ae47-cdf3-4949-b9f8-f29b153f787f14
978006loperamide hydrochloride 2 MG Oral CapsuleSCD72a7ae47-cdf3-4949-b9f8-f29b153f787f14
978006loperamide HCl 2 MG Oral CapsulePSN5dd31d61-7081-4895-8321-a77b439d7d2c4
978006loperamide hydrochloride 2 MG Oral CapsuleSCD5dd31d61-7081-4895-8321-a77b439d7d2c4
978006loperamide HCl 2 MG Oral CapsulePSN8b0ac05b-90c1-476b-b001-5801dd21701d3
978006loperamide hydrochloride 2 MG Oral CapsuleSCD8b0ac05b-90c1-476b-b001-5801dd21701d3
978006loperamide HCl 2 MG Oral CapsulePSN6deb0658-c96e-40bd-b3a3-9655a47692702
978006loperamide HCl 2 MG Oral CapsulePSNa66d2f97-8d22-482d-b18b-f58f1d882f422
978006loperamide HCl 2 MG Oral CapsulePSN59a44282-30f2-103b-e053-2a91aa0a643a2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDa66d2f97-8d22-482d-b18b-f58f1d882f422
978006loperamide hydrochloride 2 MG Oral CapsuleSCD6deb0658-c96e-40bd-b3a3-9655a47692702
978006loperamide hydrochloride 2 MG Oral CapsuleSCD59a44282-30f2-103b-e053-2a91aa0a643a2
978006loperamide HCl 2 MG Oral CapsulePSNc5322892-cb14-4a25-9b42-e62e491bc1011
978006loperamide HCl 2 MG Oral CapsulePSN3fc80822-6256-4937-e054-00144ff8d46c1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fc80822-6256-4937-e054-00144ff8d46c1
978006loperamide hydrochloride 2 MG Oral CapsuleSCDc5322892-cb14-4a25-9b42-e62e491bc1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-2100-0100378210001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01) 100 capsule1991-09-180000-00-00NoNoCurrent
0378-2100-0500378210005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05) 500 capsule1991-09-180000-00-00NoNoCurrent