Amoxicillin

Product NDC: 67253-148
11-digit product format: 672530148
Labeler code: 67253
Product ID: 67253-148_0972267b-1a1b-40da-b95c-2dc7be21720e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: DAVA Pharmaceuticals Inc
Application: ANDA065387
Marketing category: ANDA
Marketing start: 2014-08-01
Marketing end: 2020-02-29
Substance: AMOXICILLIN
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	67253-148		D	Discontinued by firm	2026-08-17
excluded package	package	67253-148	67253-148-45	D	Discontinued by firm	2026-08-17
excluded package	package	67253-148	67253-148-46	D	Discontinued by firm	2026-08-17
excluded package	package	67253-148	67253-148-47	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 · 48 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67253-148-47	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67253-148-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67253-148-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67253-148-47	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67253-148-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67253-148-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67253-148-47	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67253-148-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67253-148-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67253-148-47	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67253-148-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67253-148-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67253-148-47	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67253-148-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67253-148-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67253-148-47	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67253-148-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67253-148-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67253-148-47	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67253-148-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67253-148-46	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67253-148-47	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67253-148-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67253-148-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67253-148-47	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67253-148-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67253-148-46	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67253-148-47	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67253-148-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67253-148-46	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67253-148-47	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67253-148-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67253-148-46	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67253-148-47	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67253-148-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67253-148-46	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065387-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26
A065387-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065387-001	AB
A065387-002	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	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`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	A065387-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67253-148-45	ML - Milliliter	67253-148	719223ac-64c4-4915-bf8c-0b65ad84dd35	1	2015-08-04
67253-148-46	ML - Milliliter	67253-148	4125a59e-c355-47e7-a69b-bce66cc6d76f	1	2015-08-04
67253-148-47	ML - Milliliter	67253-148	5c1404d8-a613-4304-b6c0-4502a6d627ef	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC]	11

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	669a243e-249d-4ccb-9693-66de073e53bb	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals, Inc.	88e76bdd-39f2-48c4-91ca-609511afd382	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8dba39df-5df8-31aa-e053-2a95a90adae1	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76f315c4-acbc-76c1-e053-2a91aa0aebcd	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bac30bb-1dbc-41de-ad50-0a1883f96198	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7f75de78-2228-48e0-8405-bf631ca431ab	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e4bd448e-7911-4ae3-b136-a66d13e2ebed	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387