Amoxicillin

Product NDC: 68788-9032
11-digit product format: 687889032
Labeler code: 68788
Product ID: 68788-9032_11f5d0c7-4933-4d96-b974-ed1f985b9ae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA065291
Marketing category: ANDA
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9032		D	Discontinued by firm	2026-08-17
excluded package	package	68788-9032	68788-9032-2	D	Discontinued by firm	2026-08-17
excluded package	package	68788-9032	68788-9032-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-9032	68788-9032-4	D	Discontinued by firm	2026-08-17

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 · 56 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9032-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9032-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9032-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9032-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9032-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9032-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9032-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9032-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9032-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9032-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9032-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9032-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9032-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9032-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9032-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9032-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9032-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9032-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9032-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9032-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9032-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9032-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9032-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9032-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9032-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9032-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9032-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9032-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9032-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9032-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9032-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9032-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9032-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9032-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9032-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9032-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-9032-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-9032-4	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-9032-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68788-9032-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68788-9032-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68788-9032-4	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065291-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		2007-02-05
A065291-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		2007-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065291-001	AB
A065291-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065291-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68788-9032-2	2020-11-05	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
68788-9032-3	2020-11-05	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
68788-9032-4	2020-11-05	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
68788-9032-2	2020-01-31	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
68788-9032-3	2020-01-31	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
68788-9032-4	2020-01-31	Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	6

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	18a4f555-a537-4c40-9bb2-dc3bd782fa27	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	96057ce7-9516-4239-9974-5e9691b44c9b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	039d2677-b04f-436c-e063-6294a90ac519	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	fd071263-b750-4831-9fc5-de112a5f685b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	b988349d-2198-4dbb-a231-9ba37262ce28	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	364f969d-3037-4dff-b04b-304bca27442e	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	521f7a05-4e6d-447f-b38e-00c4d623703b	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg	Preferred Pharmaceuticals, Inc.	2017-04-28	HUMAN PRESCRIPTION DRUG LABEL	7