Home NDC 72578-138-77 Loperamide hydrochloride
Product NDC 72578-138
Requested package NDC 72578-138-77
11-digit product format 725780138
Labeler code 72578
Product ID 72578-138_50a14097-cb3f-4064-97d8-2a662c5a4ad0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loperamide hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA217471
Marketing category ANDA
Marketing start 2023-06-25
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 43 .
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 A217471-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217471-001 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 2026-09-14 22:38:34 2026-08 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217471-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-03-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 72578-138-01 Loperamide hydrochloride 100 in 1 BOTTLE CAPSULE 100 1 72578-138-05 Loperamide hydrochloride 500 in 1 BOTTLE CAPSULE 500 1 72578-138-30 Loperamide hydrochloride 10 in 1 BLISTER PACK CAPSULE 10 1 72578-138-77 Loperamide hydrochloride 10 in 1 CARTON CAPSULE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-138 LOPERAMIDE HYDROCHLORIDE CAPSULE [VIONA PHARMACEUTICALS INC] 1 Current NDC, 4 package rows 20230625_330677ff-5426-40bd-af45-e3836cb77893.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 · 2 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 72578-138-77 72578013877 10 BLISTER PACK in 1 CARTON (72578-138-77) / 10 CAPSULE in 1 BLISTER PACK (72578-138-30) 10 blister pack 2023-06-25 No No Current