Home NDC 25000-001 Loperamide Hydrochloride 2mg
Product NDC 25000-001
11-digit product format 250000001
Labeler code 25000
Product ID 25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride Tablets USP, 2mg
Dosage form TABLET
Route ORAL
Labeler MARKSANS PHARMA LIMITED
Application ANDA220153
Marketing category ANDA
Marketing start 2025-11-19
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 A220153-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2025-11-17
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 2026-02-19 14:30 UTC 2026-02 A220153-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2025-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220153-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2025-11-17 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220153-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2025-11-17 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Loperamide Hydrochloride 2mg
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 25000-001-83 Loperamide Hydrochloride 2mg 4 in 1 CARTON TABLET 4 3 25000-001-83 Loperamide Hydrochloride 2mg 6 in 1 BLISTER PACK TABLET 6 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25000-001-83 25000000183 4 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACK 4 blister pack 2025-11-19 No No Current