FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
81033-067
11-digit product format
810330067
Labeler code
81033
Product ID
81033-067_52e6ecd3-7e31-a74b-e063-6294a90ab15c
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA220100
Marketing category
ANDA
Marketing start
2024-11-13
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

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
52e6ecc5-5f3d-9989-e063-6294a90af2dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

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
ndc (product): 81033-067
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81033-067-348103300673430 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07) 2026-06-30NoNoCurrent
81033-067-358103300673530 CUP, UNIT-DOSE in 1 CARTON (81033-067-35) / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15) 2026-06-30NoNoCurrent