Home NDC 50383-618-04 Loperamide Hydrochloride
Product NDC 50383-618
Requested package NDC 50383-618-04
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074352-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 CHERRY INACTIVE INGREDIENT BUC5I9595W LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 MINT INACTIVE INGREDIENT FV98Z8GITP LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 4 LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 CHERRY INACTIVE INGREDIENT BUC5I9595W LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 MINT INACTIVE INGREDIENT FV98Z8GITP LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 CHERRY INACTIVE INGREDIENT BUC5I9595W LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 MINT INACTIVE INGREDIENT FV98Z8GITP LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-618-04 50383061804 1 BOTTLE in 1 CARTON (50383-618-04) > 118 mL in 1 BOTTLE 1 bottle 1995-11-17 0000-00-00 No No Current