Home NDC 16714-476-01 Amoxicillin and Clavulanate Potassium
Product NDC 16714-476
Requested package NDC 16714-476-01
11-digit product format 167140476
Labeler code 16714
Product ID 16714-476_3327c23e-bb50-425b-989d-eea2568c99f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar RxLLC
Application ANDA065189
Marketing category ANDA
Marketing start 2015-11-01
Marketing end 2026-06-30
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 250; 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
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 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065189-001 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 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065189-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET / ORAL AB RS 2005-08-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-476-01 Amoxicillin and Clavulanate Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 18
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 [NORTHSTAR RXLLC] 10 CLAVULANATE POTASSIUM ACTIVE INGREDIENT Q42OMW3AT8 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 CLAVULANIC ACID ACTIVE MOIETY 23521W1S24 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-476 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 17 Current NDC, Legacy NDC, 1 package rows 20240511_d6bff811-a6ea-4e4e-a4eb-b34b966cdb40.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 · 2 matching rows.
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 16714-476-01 16714047601 30 TABLET, FILM COATED in 1 BOTTLE (16714-476-01) 2015-11-01 2026-06-30 No No Current