Home NDC 55910-155 Loperamide Hydrochloride
Product NDC 55910-155
11-digit product format 559100155
Labeler code 55910
Product ID 55910-155_4db35024-40dc-22ee-e063-6394a90a0946
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler DOLGENCORP INC
Application ANDA220100
Marketing category ANDA
Marketing start 2026-03-30
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 1 mg/7.5mL
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A220100-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2025-09-19
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 A220100-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220100-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220100-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2025-09-19 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Loperamide Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
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 1250685 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 55910-155-55 Loperamide Hydrochloride 120 mL in 1 BOTTLE SOLUTION 120 1
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 · 3 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 55910-155-55 55910015555 120 mL in 1 BOTTLE (55910-155-55) 120 ml 2026-03-30 No No Current