Home NDC 71335-2487-2 Loperamide Hydrochloride
Product NDC 71335-2487
Requested package NDC 71335-2487-2
11-digit product format 713352487
Labeler code 71335
Product ID 71335-2487_e99e3001-97ad-4342-93b3-b66d83c15c85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
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 2027-12-31
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 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 2026-09-14 22:38:34 2026-08 A216876-001 LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE / ORAL AB 2023-01-26 84e616aacf4f…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# 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 2027-12-31 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 71335-2487-0 Loperamide Hydrochloride 50 in 1 BOTTLE CAPSULE 50 2 71335-2487-1 Loperamide Hydrochloride 15 in 1 BOTTLE CAPSULE 15 2 71335-2487-2 Loperamide Hydrochloride 30 in 1 BOTTLE CAPSULE 30 2 71335-2487-3 Loperamide Hydrochloride 20 in 1 BOTTLE CAPSULE 20 2 71335-2487-4 Loperamide Hydrochloride 12 in 1 BOTTLE CAPSULE 12 2 71335-2487-5 Loperamide Hydrochloride 60 in 1 BOTTLE CAPSULE 60 2 71335-2487-6 Loperamide Hydrochloride 24 in 1 BOTTLE CAPSULE 24 2 71335-2487-7 Loperamide Hydrochloride 14 in 1 BOTTLE CAPSULE 14 2 71335-2487-8 Loperamide Hydrochloride 9 in 1 BOTTLE CAPSULE 9 2 71335-2487-9 Loperamide Hydrochloride 5 in 1 BOTTLE CAPSULE 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2487 LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 1 Current NDC, 10 package rows 20240920_a2594967-e737-4a23-a710-290ca0e6a272.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 ndc (package): 71335-2487-2 ndc (product): 71335-2487 ndc11 (package): 71335248702 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2487-2 71335248702 30 CAPSULE in 1 BOTTLE (71335-2487-2) 30 capsule 2024-09-18 No No Current