FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
68151-0618
11-digit product format
681510618
Labeler code
68151
Product ID
68151-0618_4f6b4550-c33c-45ef-8b6d-ea950337bf52
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA074352
Marketing category
ANDA
Marketing start
1995-11-17
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/5mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-0618IInactivated by FDA2026-07-31
excluded packagepackage68151-061868151-0618-1IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074352-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17

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
2026-08-01 22:54:322026-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0618-12020-01-31C16284748780-19d75b9d1-1ee1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0618-1Loperamide Hydrochloride1 mL in 1 SYRINGE, PLASTICSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0618LOPERAMIDE HYDROCHLORIDE SOLUTION [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20171229_0f7e440d-0d62-402d-856d-e08198c6004f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977986loperamide HCl 1 MG in 5 mL Oral SolutionPSN0f7e440d-0d62-402d-856d-e08198c6004f3
977986loperamide hydrochloride 0.2 MG/ML Oral SolutionSCD0f7e440d-0d62-402d-856d-e08198c6004f3
977986loperamide hydrochloride 1 MG per 5 ML Oral SolutionSY0f7e440d-0d62-402d-856d-e08198c6004f3
977986loperamide hydrochloride 2 MG per 10 ML Oral SolutionSY0f7e440d-0d62-402d-856d-e08198c6004f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68151-0618-1681510618011 mL in 1 SYRINGE, PLASTIC1 mlHistorical