Home NDC 50268-050-11 NDC 50268-050-11 - Acebutolol Hydrochloride This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 50268-050
Requested NDC 50268-050-11
Package NDCs from labels 50268-050-11, 50268-050-15
Manufacturer AvPAK
Effective date 2025-09-18
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-050-11 Acebutolol Hydrochloride 1 in 1 BLISTER PACK CAPSULE 1 18 50268-050-15 Acebutolol Hydrochloride 50 in 1 BOX CAPSULE 50 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-050 ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK] 17 Current NDC, Legacy NDC, 2 package rows 20240110_ff68a002-d46d-4f9f-0705-427844ea3655.zip
DailyMed Socrata Ingredients# 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 ยท 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE AvKARE fa40a564-a579-15c1-e053-6294a90ad8e9 2026-01-13 Warnings, Adverse reactions Exact identifier application number: ANDA075047 rxcui: 998689 unii: B025Y34C54 Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE Golden State Medical Supply, Inc. f037a079-fde6-3588-e053-2995a90a6621 2025-12-17 Warnings, Adverse reactions Exact identifier rxcui: 998685 rxcui: 998689 unii: B025Y34C54 Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE ANI Pharmaceuticals, Inc. 48bded12-09c7-47f2-b162-ec970a77f2d8 2025-11-07 Warnings, Adverse reactions Exact identifier rxcui: 998685 rxcui: 998689 unii: B025Y34C54 Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE AvPAK ff68a002-d46d-4f9f-0705-427844ea3655 2025-09-18 Warnings, Adverse reactions Exact identifier application number: ANDA075047 ndc (package): 50268-050-15 ndc (package): 50268-050-11 ndc (product): 50268-050 ndc11 (package): 50268005011 rxcui: 998689 spl id: 3f158c97-90b4-1c5e-e063-6294a90a6a65 spl set id: ff68a002-d46d-4f9f-0705-427844ea3655 unii: B025Y34C54 Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE Amneal Pharmaceuticals of New York LLC fe2cd5c0-ee16-4bcb-ad92-3755881dbe79 2024-12-11 Warnings, Adverse reactions Exact identifier application number: ANDA075047 ndc (product): 53746-669 rxcui: 998685 rxcui: 998689 spl id: 32106d1d-d15a-41e6-9e2a-57394e8ae558 spl set id: fe2cd5c0-ee16-4bcb-ad92-3755881dbe79 unii: B025Y34C54 Acebutolol Hydrochloride ACEBUTOLOL HYDROCHLORIDE Amneal Pharmaceuticals LLC 28f8c26c-a1e1-4485-a45f-05c82f7a34b5 2024-10-23 Warnings, Adverse reactions Exact identifier application number: ANDA075047 rxcui: 998685 rxcui: 998689 unii: B025Y34C54 Anubis Barcelona GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE ANUBIS COSMETICS SL eb651769-4d98-2b3b-e053-2a95a90a36b0 2023-09-01 Warnings Exact identifier unii: H3R47K3TBD Anubis Barcelona Total Hydrating BETAINE, GLYCERIN, POLYSORBATE 20 ANUBIS COSMETICS SL eaefe3b9-9064-18b1-e053-2a95a90a5765 2023-09-01 Warnings Exact identifier unii: H3R47K3TBD Anubis Barcelona New Even LACTIC ACID, CITRIC ACID, GLYCOLIC ACID ANUBIS COSMETICS SL eaeeb6e0-5322-20c4-e053-2995a90a9fd9 2023-09-01 Warnings Exact identifier unii: H3R47K3TBD
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.