FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
42799-605
11-digit product format
427990605
Labeler code
42799
Product ID
42799-605_462e0177-dc7f-6e57-e063-6394a90a471a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA215001
Marketing category
ANDA
Marketing start
2020-09-25
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
42799-605-01Loperamide Hydrochloride100 in 1 BOTTLECAPSULE1005
42799-605-02Loperamide Hydrochloride500 in 1 BOTTLECAPSULE5005
42799-605-03Loperamide Hydrochloride30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-605-01EA - Each42799-6059c9a860b-2c96-4f1c-b106-242d1e98dbb912022-03-09
42799-605-02EA - Each42799-605506773d6-6583-4299-9489-51fbec8fc96512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-605LOPERAMIDE HYDROCHLORIDE CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, Legacy NDC, 3 package rows20211008_d92819f1-d02d-4959-a019-17d44df6ed2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7102
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7102
978006loperamide HCl 2 MG Oral CapsulePSNd92819f1-d02d-4959-a019-17d44df6ed2f5
978006loperamide hydrochloride 2 MG Oral CapsuleSCDd92819f1-d02d-4959-a019-17d44df6ed2f5
978006loperamide HCl 2 MG Oral CapsulePSN396f7e13-b357-52be-e063-6394a90a92fc3
978006loperamide hydrochloride 2 MG Oral CapsuleSCD396f7e13-b357-52be-e063-6394a90a92fc3
978006loperamide HCl 2 MG Oral CapsulePSN4d69532c-c71a-4880-9f74-4b37d912cabd2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD4d69532c-c71a-4880-9f74-4b37d912cabd2
978006loperamide HCl 2 MG Oral CapsulePSN1f3465d3-b43e-a6c0-e063-6294a90adef41
978006loperamide HCl 2 MG Oral CapsulePSN619c6d6a-7eca-4f89-9913-d4e9388515fa1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1f3465d3-b43e-a6c0-e063-6294a90adef41
978006loperamide hydrochloride 2 MG Oral CapsuleSCD619c6d6a-7eca-4f89-9913-d4e9388515fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-605-0142799060501100 CAPSULE in 1 BOTTLE (42799-605-01) 100 capsule2020-09-250000-00-00NoNoCurrent
42799-605-0242799060502500 CAPSULE in 1 BOTTLE (42799-605-02) 500 capsule2020-09-250000-00-00NoNoCurrent
42799-605-034279906050330 CAPSULE in 1 BOTTLE (42799-605-03) 30 capsule2020-09-250000-00-00NoNoCurrent