Home NDC 43598-770 Loperamide Hydrochloride
Product NDC 43598-770
11-digit product format 435980770
Labeler code 43598
Product ID 43598-770_9e844085-911a-6aff-3f42-27056b1de246
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA213070
Marketing category ANDA
Marketing start 2021-10-22
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213070-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11
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.
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 2026-08-18 06:07:40 2026-07 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213070-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL 2021-08-11 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Loperamide Hydrochloride
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978006 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 43598-770-24 Loperamide Hydrochloride 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 1 43598-770-24 Loperamide Hydrochloride 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-770 LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [DR. REDDY'S LABORATORIES INC.] 1 Current NDC, 2 package rows 20230628_6fe91ddc-06b6-3a51-2b48-f6f11361ab73.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 1 · 3 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 43598-770-24 43598077024 2 BLISTER PACK in 1 CARTON (43598-770-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2023-08-01 No No Current