Home NDC 70518-2191 Amoxicillin
Product NDC 70518-2191
11-digit product format 705182191
Labeler code 70518
Product ID 70518-2191_5720c9b4-e4b6-59e3-e063-6394a90a189d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA065256
Marketing category ANDA
Marketing start 2019-07-09
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 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 · 11 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…
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 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 · 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 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…2019-12-13 00:20 UTC 2019-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 70518-2191-0 Amoxicillin 20 in 1 BLISTER PACK TABLET, FILM COATED 20 16 70518-2191-1 Amoxicillin 30 in 1 BLISTER PACK TABLET, FILM COATED 30 16 70518-2191-2 Amoxicillin 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 16 70518-2191-3 Amoxicillin 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 16 70518-2191-4 Amoxicillin 14 in 1 BLISTER PACK TABLET, FILM COATED 14 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2191 AMOXICILLIN TABLET, FILM COATED [REMEDYREPACK INC.] 14 Current NDC, Legacy NDC, 5 package rows 20250309_9618d038-e880-47f6-b8d7-bbf8ab35364d.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 70518-2191-0 70518219100 20 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-0) 2019-07-09 0000-00-00 No No Current 70518-2191-1 70518219101 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-1) 2019-07-09 0000-00-00 No No Current 70518-2191-2 70518219102 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-2) 2019-07-19 0000-00-00 No No Current 70518-2191-3 70518219103 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2191-3) 2019-07-19 0000-00-00 No No Current 70518-2191-4 70518219104 14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2191-4) 2020-07-08 0000-00-00 No No Current