Home NDC 41250-224-82 anti diarrheal
Product NDC 41250-224
Requested package NDC 41250-224-82
11-digit product format 412500224
Labeler code 41250
Product ID 41250-224_24d1aebe-d698-4529-9850-0bf50ad90366
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA075232
Marketing category ANDA
Marketing start 2003-03-05
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A075232-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06
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 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 25 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base anti diarrheal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978010 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-224-01 anti diarrheal 96 in 1 BOTTLE TABLET, FILM COATED 96 8 41250-224-01 anti diarrheal 2 in 1 CARTON TABLET, FILM COATED 2 8 41250-224-53 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8 41250-224-53 anti diarrheal 12 in 1 CARTON TABLET, FILM COATED 12 8 41250-224-62 anti diarrheal 24 in 1 CARTON TABLET, FILM COATED 24 8 41250-224-62 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8 41250-224-67 anti diarrheal 1 in 1 CARTON TABLET, FILM COATED 1 8 41250-224-67 anti diarrheal 48 in 1 BOTTLE TABLET, FILM COATED 48 8 41250-224-80 anti diarrheal 1 in 1 CARTON TABLET, FILM COATED 1 8 41250-224-80 anti diarrheal 96 in 1 BOTTLE TABLET, FILM COATED 96 8 41250-224-82 anti diarrheal 1 in 1 CARTON TABLET, FILM COATED 1 8 41250-224-82 anti diarrheal 200 in 1 BOTTLE TABLET, FILM COATED 200 8 41250-224-91 anti diarrheal 6 in 1 CARTON TABLET, FILM COATED 6 8 41250-224-91 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-224 ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 8 Current NDC, Legacy NDC, 14 package rows 20240621_06a0530b-b06a-466b-b366-82a2a9f7c05c.zip
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 41250-224-82 41250022482 1 BOTTLE in 1 CARTON (41250-224-82) > 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-04-01 0000-00-00 No No Current