Home NDC 63187-320 amoxicillin and clavulanate potassium
Product NDC 63187-320
11-digit product format 631870320
Labeler code 63187
Product ID 63187-320_8c98b649-b901-4213-9713-757845f5997a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Proficient Rx LP
Application NDA050725
Marketing category NDA
Marketing start 1990-10-22
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 400; 57 mg/5mL; mg/5mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N050725-001 AUGMENTIN '200' AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 N050725-002 AUGMENTIN '400' AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31
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 · 86 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 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050725-001 AUGMENTIN '200' 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050725-002 AUGMENTIN '400' 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL RLD 1996-05-31 74a2ff9319b5…
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 400 mg/5mL CLAVULANATE POTASSIUM 57 mg/5mL
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 617430 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 63187-320-00 amoxicillin and clavulanate potassium 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 CLAVULANATE POTASSIUM ACTIVE INGREDIENT Q42OMW3AT8 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 CLAVULANIC ACID ACTIVE MOIETY 23521W1S24 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-320 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 1 package rows 20191121_1f252ad3-373c-4a6d-96e7-53ba820d201b.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 · 1 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 63187-320-00 63187032000 100 mL in 1 BOTTLE (63187-320-00) 100 ml 2015-02-02 0000-00-00 No No Current