Home NDC 16714-478-02 Amoxicillin and Clavulanate Potassium
Product NDC 16714-478
Requested package NDC 16714-478-02
11-digit product format 167140478
Labeler code 16714
Product ID 16714-478_f3bb6512-380e-4461-8d15-78de062caebd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar RxLLC
Application ANDA065093
Marketing category ANDA
Marketing start 2015-11-01
Marketing end 0000-00-00
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 875 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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065093-001 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 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 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.
DailyMed Product Concepts# 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] 1 CLAVULANATE POTASSIUM ACTIVE INGREDIENT Q42OMW3AT8 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CLAVULANIC ACID ACTIVE MOIETY 23521W1S24 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC] 1
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 16714-478-02 16714047802 100 TABLET, FILM COATED in 1 BOTTLE (16714-478-02) 2015-11-01 0000-00-00 No No Current