Home NDC 63187-729 Amoxicillin
Product NDC 63187-729
11-digit product format 631870729
Labeler code 63187
Product ID 63187-729_ebd359ee-3a33-476d-99fc-2a8846cbd40c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA065256
Marketing category ANDA
Marketing start 2005-11-09
Substance AMOXICILLIN
Active strength 875 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
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 44 .
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 A065256-001 AMOXICILLIN AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 A065256-002 AMOXICILLIN AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 88 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 2026-10-15 13:18:30 2026-09 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 875 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308194 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 63187-729-14 Amoxicillin 14 in 1 BOTTLE TABLET, FILM COATED 14 3 63187-729-20 Amoxicillin 20 in 1 BOTTLE TABLET, FILM COATED 20 3 63187-729-21 Amoxicillin 21 in 1 BOTTLE TABLET, FILM COATED 21 3 63187-729-28 Amoxicillin 28 in 1 BOTTLE TABLET, FILM COATED 28 3 63187-729-30 Amoxicillin 30 in 1 BOTTLE TABLET, FILM COATED 30 3 63187-729-40 Amoxicillin 40 in 1 BOTTLE TABLET, FILM COATED 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-729 AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 6 package rows 20191121_586a5911-e30b-40ed-a056-9e67920ca951.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 Marketing start Marketing end Sample Exclude flag Status 63187-729-14 63187072914 14 TABLET, FILM COATED in 1 BOTTLE (63187-729-14) 2016-08-01 0000-00-00 No No Current 63187-729-20 63187072920 20 TABLET, FILM COATED in 1 BOTTLE (63187-729-20) 2016-08-01 0000-00-00 No No Current 63187-729-21 63187072921 21 TABLET, FILM COATED in 1 BOTTLE (63187-729-21) 2016-08-01 0000-00-00 No No Current 63187-729-28 63187072928 28 TABLET, FILM COATED in 1 BOTTLE (63187-729-28) 2016-08-01 0000-00-00 No No Current 63187-729-30 63187072930 30 TABLET, FILM COATED in 1 BOTTLE (63187-729-30) 2016-08-01 0000-00-00 No No Current 63187-729-40 63187072940 40 TABLET, FILM COATED in 1 BOTTLE (63187-729-40) 2016-08-01 0000-00-00 No No Current