FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
69452-405
11-digit product format
694520405
Labeler code
69452
Product ID
69452-405_4bd07c07-575e-1543-e063-6294a90a9b3c
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA220100
Marketing category
ANDA
Marketing start
2026-03-02
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct69452-405UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage69452-40569452-405-99UNFINISHEDActive or certified unfinished drug listing2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220100-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220100-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-1984e616aacf4f…
2026-08-18 06:07:402026-07A220100-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220100-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220100-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-1931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220100-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2025-09-19a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Loperamide Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/7.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1250685Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bd0939e-c172-d962-e063-6394a90a44b5Available on FDA.report

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
69452-405-55Loperamide Hydrochloride120 mL in 1 BOTTLESOLUTION1201
69452-405-93Loperamide Hydrochloride240 mL in 1 BOTTLESOLUTION2401

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEKesin Pharma Corporation52e6ecc5-5f3d-9989-e063-6294a90af2dc2026-06-30WarningsExact identifier
application applno (ANDA): 220100
application number: ANDA220100
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDOLGENCORP INC4db35031-f765-39a6-e063-6394a90a40c92026-03-20WarningsExact identifier
application applno (ANDA): 220100
application number: ANDA220100
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDE ORALBionpharma Inc.4bd0939e-c172-d962-e063-6394a90a44b52026-02-27WarningsExact identifier
application applno (ANDA): 220100
application number: ANDA220100
ndc (product): 69452-405

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN4bd0939e-c172-d962-e063-6394a90a44b51
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD4bd0939e-c172-d962-e063-6394a90a44b51
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY4bd0939e-c172-d962-e063-6394a90a44b51
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY4bd0939e-c172-d962-e063-6394a90a44b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-405-5569452040555120 mL in 1 BOTTLE (69452-405-55) 120 ml2026-03-02NoNoCurrent
69452-405-9369452040593240 mL in 1 BOTTLE (69452-405-93) 240 ml2026-03-03NoNoCurrent
69452-405-9969452040599120 mL in 1 BOTTLE (69452-405-99)120 ml27-FEB-26Current