Home NDC 50580-317 Imodium
Product NDC 50580-317
11-digit product format 505800317
Labeler code 50580
Product ID 50580-317_3f75a619-8881-0bb3-e063-6394a90a1bcc
Type HUMAN OTC DRUG
Nonproprietary name Loperamide hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application ANDA075232
Marketing category ANDA
Marketing start 2015-07-13
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075232-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Imodium
Brand name suffix A-D
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978010 Internal RxNorm lookup 978013 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 50580-317-01 ImodiumA-D 1 in 1 CARTON TABLET, FILM COATED 1 13 50580-317-01 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-03 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-03 ImodiumA-D 4 in 1 CARTON TABLET, FILM COATED 4 13 50580-317-04 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-04 ImodiumA-D 6 in 1 CARTON TABLET, FILM COATED 6 13 50580-317-05 ImodiumA-D 8 in 1 CARTON TABLET, FILM COATED 8 13 50580-317-05 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-06 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-06 ImodiumA-D 2 in 1 CARTON TABLET, FILM COATED 2 13 50580-317-12 ImodiumA-D 6 in 1 BLISTER PACK TABLET, FILM COATED 6 13 50580-317-12 ImodiumA-D 2 in 1 CARTON TABLET, FILM COATED 2 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loperamide hydrochloride ACTIVE INGREDIENT 77TI35393C IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 Loperamide ACTIVE MOIETY 6X9OC3H4II IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-317 IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 12 Current NDC, Legacy NDC, 12 package rows 20241109_01da76d0-1979-4c45-9d39-c72ae4e4ffe2.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 1 of 2 · 25 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 50580-317-01 50580031701 1 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2015-07-13 0000-00-00 No No Current 50580-317-03 50580031703 4 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2015-07-13 0000-00-00 No No Current 50580-317-04 50580031704 6 in 1 BLISTER PACK Historical 50580-317-05 50580031705 8 BLISTER PACK in 1 CARTON (50580-317-05) > 6 TABLET, FILM COATED in 1 BLISTER PACK 8 blister pack 2015-07-13 0000-00-00 No No Current 50580-317-06 50580031706 2 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2020-02-10 0000-00-00 No No Current 50580-317-12 50580031712 2 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-01-29 No No Current