Home NDC 41250-813 loperamide hydrochloride
Product NDC 41250-813
11-digit product format 412500813
Labeler code 41250
Product ID 41250-813_a32bdf4f-50d7-4697-a805-d32f6bee657d
Type HUMAN OTC DRUG
Nonproprietary name loperamide HCl
Dosage form SOLUTION
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA091292
Marketing category ANDA
Marketing start 2018-07-10
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 43 .
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 A091292-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 41250-813-26 loperamide hydrochloride 120 mL in 1 BOTTLE SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-813 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 2 Current NDC, Legacy NDC, 1 package rows 20200124_5f693cf6-dced-425f-b25e-37a9f8ec17d6.zip
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 2 of 2 · 27 matching rows.
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 41250-813-26 41250081326 120 mL in 1 BOTTLE (41250-813-26) 120 ml 2018-07-10 0000-00-00 No No Current