Home NDC 0615-8497 Loperamide Hydrochloride
Product NDC 0615-8497
11-digit product format 006158497
Labeler code 0615
Product ID 0615-8497_96819325-1225-4982-8e6a-85b217a6b6d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA216876
Marketing category ANDA
Marketing start 2023-01-26
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 A216876-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216876-001 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 2026-08-18 06:07:40 2026-07 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 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 0615-8497-39 Loperamide Hydrochloride 30 in 1 BLISTER PACK CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8497 LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 2 Current NDC, 1 package rows 20240816_f245e8f4-e06e-492e-8c46-af1fce1633fc.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack a2594967-e737-4a23-a710-290ca0e6a272 2026-05-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216876 application number: ANDA216876 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Advagen Pharma Ltd., 03c907d5-87f8-47a6-9544-5a24f5272739 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216876 application number: ANDA216876 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs f245e8f4-e06e-492e-8c46-af1fce1633fc 2024-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216876 application number: ANDA216876 ndc (product): 0615-8497
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0615-8497-39 00615849739 30 CAPSULE in 1 BLISTER PACK (0615-8497-39) 30 capsule 2024-01-12 No No Current