Home NDC 68071-2911 Amoxicillin
Product NDC 68071-2911
11-digit product format 680712911
Labeler code 68071
Product ID 68071-2911_4b2134dc-4c34-0cfb-e063-6294a90acd23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA065256
Marketing category ANDA
Marketing start 2005-11-09
Substance AMOXICILLIN
Active strength 500 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-2911-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-2911-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-2911-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-2911-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-2911-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-2911-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2911-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2911-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2911-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 500 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 308192 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2911-1 Amoxicillin 100 in 1 BOTTLE TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2911 AMOXICILLIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 1 Current NDC, Legacy NDC, 1 package rows 20230111_f1eee459-9021-b26e-e053-2995a90a7291.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 68071-2911-1 68071291101 100 TABLET, FILM COATED in 1 BOTTLE (68071-2911-1) 2023-01-10 0000-00-00 No No Current