Home NDC 55289-845 Amoxicillin and Clavulanate Potassium
Product NDC 55289-845
11-digit product format 552890845
Labeler code 55289
Product ID 55289-845_419b7d75-b6cc-e646-e063-6294a90a8d2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA065101
Marketing category ANDA
Marketing start 2002-10-31
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 500; 125 mg/1; mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [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 1 .
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 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065101-001 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.
Product history page 1 of 2 · 41 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 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM PD-Rx Pharmaceuticals, Inc. cc445a39-d84c-4b76-9fb8-ae302e7cd96b 2025-10-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 ndc (product): 55289-845 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM PD-Rx Pharmaceuticals, Inc. 0425932a-f6e1-49a6-8480-720f179ace14 2025-10-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Proficient Rx LP 482511ed-4531-45ec-a4eb-c600aeb03325 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Teva Pharmaceuticals USA, Inc. 963e7bea-ff5d-420a-9cb2-e4aefb534b33 2024-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Asclemed USA, Inc. 8c4125d4-d074-40d4-9def-d3a528fc8c8e 2023-09-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101
Additional Listing Data#
Finished product Yes
Brand name base Amoxicillin and Clavulanate Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 500 mg/1 CLAVULANATE POTASSIUM 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup Q42OMW3AT8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617296 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 55289-845-06 Amoxicillin and Clavulanate Potassium 6 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 6 31 55289-845-20 Amoxicillin and Clavulanate Potassium 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 31 55289-845-21 Amoxicillin and Clavulanate Potassium 21 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 21 31 55289-845-28 Amoxicillin and Clavulanate Potassium 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 31 55289-845-30 Amoxicillin and Clavulanate Potassium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 CLAVULANATE POTASSIUM ACTIVE INGREDIENT Q42OMW3AT8 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 CLAVULANIC ACID ACTIVE MOIETY 23521W1S24 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-845 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 30 Current NDC, Legacy NDC, 5 package rows 20241006_cc445a39-d84c-4b76-9fb8-ae302e7cd96b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-845-06 55289084506 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06) 2012-12-06 0000-00-00 No No Current 55289-845-20 55289084520 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20) 2012-12-06 0000-00-00 No No Current 55289-845-21 55289084521 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21) 2012-12-06 0000-00-00 No No Current 55289-845-28 55289084528 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28) 2012-12-06 0000-00-00 No No Current 55289-845-30 55289084530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30) 2012-12-06 0000-00-00 No No Current