Amoxicillin

Product NDC: 68071-3292
Requested package NDC: 68071-3292-6
11-digit product format: 680713292
Labeler code: 68071
Product ID: 68071-3292_bb17392b-111a-41cd-e053-2995a90a5f2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA065271
Marketing category: ANDA
Marketing start: 2005-11-09
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-3292	68071-3292-6	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Application-product, TE code table
Application-product	TE code
A065271-001	AB
A065271-002	AB

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065271-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065271-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065271-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065271-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065271-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065271-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065271-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065271-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065271-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065271-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065271-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3292-3	2024-07-09	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-4	2024-07-09	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-6	2024-07-09	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-8	2024-07-09	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-9	2024-07-09	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-3	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-4	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-6	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-8	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-9	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-3	2021-02-11	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-4	2021-02-11	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-6	2021-02-11	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-8	2021-02-11	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-9	2021-02-11	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-3	2021-01-29	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-4	2021-01-29	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-6	2021-01-29	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-8	2021-01-29	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-3292-9	2021-01-29	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

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 1 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	1d0d8bc4-137e-ef10-e063-6294a90acf62	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	53548597-347b-42a9-916c-e88cd27b8dcd	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ef03286b-4ba7-4952-9ab1-90cacf300504	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5155ca5d-fe58-42b4-e063-6394a90ab135	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin 500 mg	AMOXICILLIN	Health Department, Oklahoma State	f049551b-4708-eb13-e053-2a95a90afd1f	2025-12-13		Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	32b224c2-1354-4b58-b082-b93330e6962b	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	071086f5-e4ed-b1d9-e063-6294a90ad304	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bbaeb509-ad04-4668-a1db-4358038893f2	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3292-6	68071329206	6 CAPSULE in 1 BOTTLE (68071-3292-6)	6 capsule	2017-05-25	0000-00-00	No	No	Current