Home NDC 69168-248 Anti-Diarrheal
Product NDC 69168-248
11-digit product format 691680248
Labeler code 69168
Product ID 69168-248_ef9b20dc-0119-49c1-bc31-2c9fc1f4d772
Type HUMAN OTC DRUG
Nonproprietary name Loperamide HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Allegiant Health
Application ANDA076497
Marketing category ANDA
Marketing start 2005-05-03
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 A076497-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10
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 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 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 · 35 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 69168-248-86 Anti-Diarrheal 6 in 1 BLISTER PACK TABLET, COATED 6 5 69168-248-86 Anti-Diarrheal 2 in 1 CARTON TABLET, COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-248 ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET, COATED [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC, 2 package rows 20210923_aca3742c-2a82-4e91-8aaf-2fce08487e56.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 69168-248-86 69168024886 2 BLISTER PACK in 1 CARTON (69168-248-86) / 6 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2005-05-03 0000-00-00 No No Current