Home NDC 68071-4982 Amoxicillin
Product NDC 68071-4982
11-digit product format 680714982
Labeler code 68071
Product ID 68071-4982_44fcbea4-7615-1d98-e063-6294a90a6b32
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 875 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4982-2 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4982-2 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4982-2 1332a3947898…d4bfe170f9cd…
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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-06-18 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2024-06-18 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2024-06-18 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2023-01-30 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2023-01-30 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2023-01-30 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-02-19 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-02-19 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-02-19 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-01-29 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-01-29 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974 2021-01-29 These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4982-2 Amoxicillin 20 in 1 BOTTLE TABLET, FILM COATED 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4982 AMOXICILLIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240619_8e6f9df1-0754-69e4-e053-2a95a90acc49.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 68071-4982-2 68071498202 20 TABLET, FILM COATED in 1 BOTTLE (68071-4982-2) 2019-07-24 0000-00-00 No No Current