FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
50383-618
11-digit product format
503830618
Labeler code
50383
Product ID
50383-618_b35dcfa7-3a19-48ae-a8c7-dc03249f9134
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA074352
Marketing category
ANDA
Marketing start
1995-11-17
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-618DDiscontinued by firm2026-07-31
excluded packagepackage50383-61850383-618-04DDiscontinued by firm2026-07-31
excluded packagepackage50383-61850383-618-06DDiscontinued by firm2026-07-31
excluded packagepackage50383-61850383-618-11DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-618-04ML - Milliliter50383-6188b63b39a-50bc-4955-a19f-2bf658aab63812012-07-24
50383-618-05ML - Milliliter50383-618cebec501-71fb-4138-b911-b4abaea5d47912013-10-17
50383-618-06ML - Milliliter50383-6184aff43b9-f08c-42f0-891d-7d579728476b12013-08-02
50383-618-10ML - Milliliter50383-61887fa7eba-05a0-4c90-b62a-deeca64cc69a12013-10-17
50383-618-11ML - Milliliter50383-618fdcbc23c-0d0d-4c51-9133-220296523bcb12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977986loperamide HCl 1 MG in 5 mL Oral SolutionPSNb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 0.2 MG/ML Oral SolutionSCDb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 1 MG per 5 ML Oral SolutionSYb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 2 MG per 10 ML Oral SolutionSYb0596b9c-326d-4795-b0a5-38c858af7a775
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-618-04503830618041 BOTTLE in 1 CARTON (50383-618-04) > 118 mL in 1 BOTTLE1 bottle1995-11-170000-00-00NoNoCurrent
50383-618-06503830618064 TRAY in 1 CASE (50383-618-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-618-05) 4 tray2015-02-270000-00-00NoNoCurrent
50383-618-11503830618114 TRAY in 1 CASE (50383-618-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-618-10) 4 tray2015-02-270000-00-00NoNoCurrent