Home NDC 65162-669 Acebutolol Hydrochloride
Product NDC 65162-669
11-digit product format 651620669
Labeler code 65162
Product ID 65162-669_6e350ff3-ef29-4f7b-acc2-5f4bfe188233
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acebutolol Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA075047
Marketing category ANDA
Marketing start 2009-12-01
Substance ACEBUTOLOL HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075047-001 ACEBUTOLOL HYDROCHLORIDE ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 A075047-002 ACEBUTOLOL HYDROCHLORIDE ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RS 1999-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL RS 1999-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075047-001 ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RS 1999-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075047-002 ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE CAPSULE / ORAL AB RS 1999-12-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acebutolol Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACEBUTOLOL HYDROCHLORIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B025Y34C54 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998685 Internal RxNorm lookup 998689 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 65162-669-10 Acebutolol Hydrochloride 100 in 1 BOTTLE CAPSULE 100 14 65162-669-50 Acebutolol Hydrochloride 500 in 1 BOTTLE CAPSULE 500 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACEBUTOLOL HYDROCHLORIDE ACTIVE INGREDIENT B025Y34C54 ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 ACEBUTOLOL ACTIVE MOIETY 67P356D8GH ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 D&c Red No. 28 INACTIVE INGREDIENT 767IP0Y5NH ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 D&c Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Fd&c Red No. 40 INACTIVE INGREDIENT WZB9127XOA ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Gelatin INACTIVE INGREDIENT 2G86QN327L ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Povidone INACTIVE INGREDIENT FZ989GH94E ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.] 8 ACEBUTOLOL HYDROCHLORIDE ACTIVE INGREDIENT B025Y34C54 ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 ACEBUTOLOL ACTIVE MOIETY 67P356D8GH ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 6 ACEBUTOLOL HYDROCHLORIDE ACTIVE INGREDIENT B025Y34C54 ACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 ACEBUTOLOL ACTIVE MOIETY 67P356D8GH ACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-669 ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 2 package rows 20241025_28f8c26c-a1e1-4485-a45f-05c82f7a34b5.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-669-10 65162066910 100 CAPSULE in 1 BOTTLE (65162-669-10) 100 capsule 2009-12-01 0000-00-00 No No Current 65162-669-50 65162066950 500 CAPSULE in 1 BOTTLE (65162-669-50) 500 capsule 2009-12-01 0000-00-00 No No Current