Home NDC 42507-224-62 anti diarrheal
Product NDC 42507-224
Requested package NDC 42507-224-62
11-digit product format 425070224
Labeler code 42507
Product ID 42507-224_be79f54a-1df5-4acc-9f17-ff7d2559d58f
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HyVee Inc
Application ANDA075232
Marketing category ANDA
Marketing start 2003-03-21
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 anti diarrheal
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 42507-224-53 anti diarrheal 12 in 1 CARTON TABLET, FILM COATED 12 4 42507-224-53 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 42507-224-62 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 42507-224-62 anti diarrheal 24 in 1 CARTON TABLET, FILM COATED 24 4 42507-224-80 anti diarrheal 96 in 1 BOTTLE TABLET, FILM COATED 96 4 42507-224-80 anti diarrheal 1 in 1 CARTON TABLET, FILM COATED 1 4 42507-224-91 anti diarrheal 6 in 1 CARTON TABLET, FILM COATED 6 4 42507-224-91 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC] 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 2 · 25 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 42507-224-62 42507022462 24 BLISTER PACK in 1 CARTON (42507-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK 24 blister pack 2003-03-21 No No Current