Home NDC 69452-271 Loperamide Hydrochloride
Product NDC 69452-271
11-digit product format 694520271
Labeler code 69452
Product ID 69452-271_0d83f614-6730-7d3a-e063-6294a90a6b11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loperamide hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bionpharma Inc.
Application ANDA215579
Marketing category ANDA
Marketing start 2021-12-01
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 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 A215579-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215579-001 AB
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 2026-02-19 14:30 UTC 2026-02 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215579-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2021-10-22 a50c72e98297…
Observed Orange Book normalized TE 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 69452-271-20 Loperamide Hydrochloride 100 in 1 BOTTLE, PLASTIC CAPSULE 100 3 69452-271-30 Loperamide Hydrochloride 500 in 1 BOTTLE, PLASTIC CAPSULE 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-271 LOPERAMIDE HYDROCHLORIDE CAPSULE [BIONPHARMA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231228_6e60cb25-6af9-4f17-b740-a5e7b5bb2a09.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE AvPAK f8992723-dd9a-bcf6-e053-6294a90aa65c 2025-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215579 application number: ANDA215579 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. df4e7076-fd25-aeb8-e053-2995a90a2aa0 2024-05-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215579 application number: ANDA215579 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack 691c5dd6-b85d-482b-a8c1-8c4b48b48dc9 2024-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215579 application number: ANDA215579 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bionpharma Inc. 6e60cb25-6af9-4f17-b740-a5e7b5bb2a09 2023-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215579 application number: ANDA215579 ndc (product): 69452-271
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 69452-271-20 69452027120 100 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-20) 100 capsule 2021-12-01 0000-00-00 No No Current 69452-271-30 69452027130 500 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-30) 500 capsule 2022-06-23 0000-00-00 No No Current