FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
69452-271
11-digit product format
694520271
Labeler code
69452
Product ID
69452-271_0d83f614-6730-7d3a-e063-6294a90a6b11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA215579
Marketing category
ANDA
Marketing start
2021-12-01
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
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
69452-271-20Loperamide Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1003
69452-271-30Loperamide Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-271-20EA - Each69452-2714984aaa7-fcc1-4a6c-b854-2930317e7baa12022-01-06
69452-271-30EA - Each69452-271cae7606b-05fd-4b52-868a-a9119b3765cc12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-271LOPERAMIDE HYDROCHLORIDE CAPSULE [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20231228_6e60cb25-6af9-4f17-b740-a5e7b5bb2a09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN691c5dd6-b85d-482b-a8c1-8c4b48b48dc9104
978006loperamide hydrochloride 2 MG Oral CapsuleSCD691c5dd6-b85d-482b-a8c1-8c4b48b48dc9104
978006loperamide HCl 2 MG Oral CapsulePSN6e60cb25-6af9-4f17-b740-a5e7b5bb2a093
978006loperamide HCl 2 MG Oral CapsulePSNdf4e7076-fd25-aeb8-e053-2995a90a2aa03
978006loperamide hydrochloride 2 MG Oral CapsuleSCD6e60cb25-6af9-4f17-b740-a5e7b5bb2a093
978006loperamide hydrochloride 2 MG Oral CapsuleSCDdf4e7076-fd25-aeb8-e053-2995a90a2aa03
978006loperamide HCl 2 MG Oral CapsulePSNebf2b8c1-dba6-12ba-e053-2995a90a4a4f2
978006loperamide HCl 2 MG Oral CapsulePSNf422ade5-8395-40e4-e053-2a95a90a40442
978006loperamide HCl 2 MG Oral CapsulePSNf8992723-dd9a-bcf6-e053-6294a90aa65c2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDebf2b8c1-dba6-12ba-e053-2995a90a4a4f2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf422ade5-8395-40e4-e053-2a95a90a40442
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf8992723-dd9a-bcf6-e053-6294a90aa65c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-271-2069452027120100 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-20) 100 capsule2021-12-010000-00-00NoNoCurrent
69452-271-3069452027130500 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-30) 500 capsule2022-06-230000-00-00NoNoCurrent