Amoxicillin

Product NDC: 68788-7812
Requested package NDC: 68788-7812-3
11-digit product format: 687887812
Labeler code: 68788
Product ID: 68788-7812_b375c593-5f19-4522-b1dc-53d796aff222
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA062216
Marketing category: ANDA
Marketing start: 2020-10-30
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 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	68788-7812	68788-7812-3	D	Discontinued by firm		2026-10-05

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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A062216-001	AMOXIL	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A062216-004	AMOXIL	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062216-001	AB
A062216-004	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062216-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062216-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062216-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062216-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062216-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062216-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062216-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062216-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062216-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062216-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062216-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062216-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062216-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062216-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062216-004	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	REMEDYREPACK INC.	4adc198e-39d8-4b3e-bfa4-278aaf4064ae	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	5a660370-9a81-33f9-e063-6394a90a6c62	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	USAntibiotics, LLC	110ba6b1-f175-48a1-8e30-616c02212538	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	0a100e76-513c-98d3-e063-6294a90adf47	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216

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
68788-7812-3	68788781203	30 CAPSULE in 1 BOTTLE, PLASTIC (68788-7812-3)	30 capsule	2020-10-30	0000-00-00	No	No	Current