Home NDC 70518-2225 Amoxicillin and Clavulanate Potassium
Product NDC 70518-2225
11-digit product format 705182225
Labeler code 70518
Product ID 70518-2225_5c402100-160e-d9f1-e063-6394a90a5264
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA091568
Marketing category ANDA
Marketing start 2019-07-19
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 875; 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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091568-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Amoxicillin and Clavulanate Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 875 mg/1 CLAVULANATE POTASSIUM 125 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-2225-0 Amoxicillin and Clavulanate Potassium 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 22 70518-2225-1 Amoxicillin and Clavulanate Potassium 30 in 1 BLISTER PACK TABLET, FILM COATED 30 22 70518-2225-2 Amoxicillin and Clavulanate Potassium 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 22 70518-2225-3 Amoxicillin and Clavulanate Potassium 20 in 1 BLISTER PACK TABLET, FILM COATED 20 22 70518-2225-4 Amoxicillin and Clavulanate Potassium 14 in 1 BLISTER PACK TABLET, FILM COATED 14 22 70518-2225-5 Amoxicillin and Clavulanate Potassium 30 in 1 BLISTER PACK TABLET, FILM COATED 30 22 70518-2225-6 Amoxicillin and Clavulanate Potassium 100 in 1 BOX TABLET, FILM COATED 100 22 70518-2225-7 Amoxicillin and Clavulanate Potassium 1 in 1 POUCH TABLET, FILM COATED 1 22 70518-2225-8 Amoxicillin and Clavulanate Potassium 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2225 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] 16 Current NDC, Legacy NDC, 9 package rows 20250309_77b82fac-3f6e-44c9-8dcc-362f01ad7a4b.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 2 of 2 · 24 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 70518-2225-0 70518222500 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-0) 2019-07-19 0000-00-00 No No Current 70518-2225-1 70518222501 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-1) 2020-06-10 0000-00-00 No No Current 70518-2225-2 70518222502 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-2) 2020-06-17 0000-00-00 No No Current 70518-2225-3 70518222503 20 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-3) 2020-08-31 0000-00-00 No No Current 70518-2225-4 70518222504 14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-4) 2020-09-30 0000-00-00 No No Current 70518-2225-5 70518222505 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-5) 2021-04-06 0000-00-00 No No Current 70518-2225-6 70518222506 100 POUCH in 1 BOX (70518-2225-6) / 1 TABLET, FILM COATED in 1 POUCH (70518-2225-7) 100 pouch 2021-10-11 0000-00-00 No No Current 70518-2225-7 70518222507 1 in 1 POUCH Historical 70518-2225-8 70518222508 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-8) 2021-12-07 0000-00-00 No No Current