Home NDC 72888-130-00 Loperamide Hydrochloride
Product NDC 72888-130
Requested package NDC 72888-130-00
11-digit product format 728880130
Labeler code 72888
Product ID 72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loperamide Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Advagen Pharma Ltd.,
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 72888-130-00 Loperamide Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 3 72888-130-01 Loperamide Hydrochloride 100 in 1 BOTTLE CAPSULE 100 3 72888-130-05 Loperamide Hydrochloride 500 in 1 BOTTLE CAPSULE 500 3 72888-130-30 Loperamide Hydrochloride 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-130 LOPERAMIDE HYDROCHLORIDE CAPSULE [ADVAGEN PHARMA LTD.,] 1 Current NDC, 4 package rows 20230403_03c907d5-87f8-47a6-9544-5a24f5272739.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 ndc (package): 72888-130-00 ndc (product): 72888-130 ndc11 (package): 72888013000 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 72888-130-00 72888013000 1000 CAPSULE in 1 BOTTLE (72888-130-00) 1000 capsule 2023-01-26 No No Current