Home NDC 68788-8972 Amoxicillin
Product NDC 68788-8972
11-digit product format 687888972
Labeler code 68788
Product ID 68788-8972_8a60d6b9-993c-4a81-a992-3ef98d1809c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA065271
Marketing category ANDA
Marketing start 2016-01-20
Marketing end 0000-00-00
Substance AMOXICILLIN
Active strength 500 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065271-001 AMOXICILLIN AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 A065271-002 AMOXICILLIN AMOXICILLIN 500MG CAPSULE / 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 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68788-8972-2 2020-01-31 C162847 48780-1 9d75b9d0-ee45-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use amoxicillin capsules safely and effectively. See full prescribing information for amoxicillin capsules, USP. Amoxicillin Capsules, USP Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 68788-8972-3 2020-01-31 C162847 48780-1 9d75b9d0-ee45-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use amoxicillin capsules safely and effectively. See full prescribing information for amoxicillin capsules, USP. Amoxicillin Capsules, USP Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 68788-8972-4 2020-01-31 C162847 48780-1 9d75b9d0-ee45-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use amoxicillin capsules safely and effectively. See full prescribing information for amoxicillin capsules, USP. Amoxicillin Capsules, USP Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8972-2 Amoxicillin 21 in 1 BOTTLE, PLASTIC CAPSULE 21 3 68788-8972-3 Amoxicillin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 3 68788-8972-4 Amoxicillin 40 in 1 BOTTLE, PLASTIC CAPSULE 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8972 AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS INC.] 3 Legacy NDC, 3 package rows 20180302_b0523dc3-668f-466f-9421-2aae3b9b5751.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 4 of 4 · 63 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68788-8972-2 68788897202 21 in 1 BOTTLE, PLASTIC Historical 68788-8972-3 68788897203 30 in 1 BOTTLE, PLASTIC Historical 68788-8972-4 68788897204 40 in 1 BOTTLE, PLASTIC Historical