Home NDC 85766-154-12 Loperamide Hydrochloride
Product NDC 85766-154
Requested package NDC 85766-154-12
11-digit product format 857660154
Labeler code 85766
Product ID 85766-154_5534bead-3750-6b8e-e063-6294a90a7c4e
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sportpharm LLC
Application ANDA074091
Marketing category ANDA
Marketing start 2026-02-06
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 2 mg/1
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 A074091-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10
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.
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 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 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 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 85766-154-06 Loperamide Hydrochloride 6 in 1 BLISTER PACK TABLET 6 1 85766-154-06 Loperamide Hydrochloride 1 in 1 CARTON TABLET 1 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 · 19 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Sportpharm LLC eb93a17e-7daf-4a9e-94a1-442039a383bd 2026-06-26 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (package): 85766-154-12 ndc (product): 85766-154 ndc11 (package): 85766015412 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Sportpharm LLC ac674e5a-94df-4a35-9854-4e66cc17e509 2026-04-24 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Private Label Distributor LOPERAMIDE HCL 2 MG Unifirst First Aid Corporation 069e7979-a223-4819-b6cf-ea2731bf156b 2025-12-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 9cf77219-c98d-487a-a5d3-61ceda6c65f5 2025-10-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Medline Industries, LP 03d68bcf-6413-4fe3-8263-39cc315452d2 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal LOPERAMIDE HCI Lil' Drug Store Products, Inc. eec84fa1-262f-6e77-e053-2995a90a325b 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal, Circle K LOPERAMIDE HCL TABLET Lil' Drug Store Products, Inc. d3aaad65-f4cd-5eb0-e053-2995a90ade84 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal, Caseys 4good LOPERAMIDE HCL Lil' Drug Store Products, Inc. 043b0ab4-8fba-37d1-e063-6394a90a4cd4 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Lil Drug Store Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Lil' Drug Store Products, Inc. fc23b13e-3005-4f23-aec2-b02a0e48ea11 2024-11-27 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Consortium, LLC b070896b-1e22-41d4-a66d-8d3be1699217 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Zee Medical Inc 07e1f89c-5bf6-4539-848a-4435e7deb0d2 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Ohm Laboratories Inc. c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Discount Drug Mart 6bc9771d-09f8-47ce-bbbd-8dd9aae97693 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Marc Glassman, Inc. 01efdce1-25ce-45ff-aeb6-f6fba00e59aa 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Valu Merchandisers Company 33335063-49a9-4e08-9d77-4cd80e94f021 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Fred's Inc. a3bf91ae-22f3-4402-b73c-de026f2d0475 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Marketing Association Inc. 237b845b-0f02-410d-9750-c95123e6142d 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. 76e32e66-4af5-47a5-83ff-cbba206975d6 2023-03-15 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 82e65393-25b7-4114-9c71-5840ee8bad84 2022-05-02 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-154-12 85766015412 2 BLISTER PACK in 1 CARTON (85766-154-12) / 6 TABLET in 1 BLISTER PACK 2 blister pack 2026-06-27 No No Current