Home NDC 0904-6256 loperamide hydrochloride
Product NDC 0904-6256
11-digit product format 009046256
Labeler code 0904
Product ID 0904-6256_1df30a0d-eb4b-4a24-bfe6-7ad5d4c0e73c
Type HUMAN OTC DRUG
Nonproprietary name loperamide HCl
Dosage form SUSPENSION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA091292
Marketing category ANDA
Marketing start 2012-03-14
Marketing end 0000-00-00
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 1 mg/7.5mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-6256-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-6256-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-6256-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-6256-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-6256-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-6256-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-6256-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-6256-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-6256-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-6256-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-6256-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-6256-20 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 cb3db0bc1861…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 WATER INACTIVE INGREDIENT 059QF0KO0R LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [MAJOR PHARMACEUTICALS] 3 LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) LIQUID [PREFERRED PHARMACEUTICALS, INC.] 2
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 · 26 matching rows.