Amoxicillin

Product NDC: 52959-613
11-digit product format: 529590613
Labeler code: 52959
Product ID: 52959-613_f97f68a9-f15b-4a49-8a24-89b2e31992cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA065322
Marketing category: ANDA
Marketing start: 2006-06-19
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 mg/5mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-613		I	Inactivated by FDA	2026-08-10
excluded package	package	52959-613	52959-613-02	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-613	52959-613-03	I	Inactivated by FDA	2026-08-10

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 · 66 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	52959-613-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-613-03	`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	52959-613-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-613-03	`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	52959-613-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-613-03	`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	52959-613-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-613-03	`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	52959-613-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-613-03	`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	52959-613-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-613-03	`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	52959-613-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-613-03	`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	52959-613-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-613-03	`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	52959-613-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-613-03	`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	52959-613-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-613-03	`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	52959-613-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-613-03	`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	52959-613-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-613-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-613-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-613-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-613-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-613-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-613-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-613-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-613-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-613-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-613-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-613-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-613-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-613-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-613-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-613-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-613-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-613-03	`e2bbac7714bc…`	`27bdfed8d636…`

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
A065322-001	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19
A065322-002	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065322-001	AB
A065322-002	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	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065322-001	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065322-002	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`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	A065322-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065322-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065322-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065322-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065322-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065322-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065322-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065322-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065322-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065322-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065322-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065322-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065322-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065322-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065322-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065322-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065322-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065322-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065322-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065322-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065322-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065322-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065322-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065322-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065322-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065322-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065322-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065322-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065322-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065322-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065322-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065322-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065322-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065322-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065322-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065322-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065322-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065322-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065322-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065322-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-613-02	2019-11-13	C162847	48780-1	97449f38-d4ab-f6ea-e053-dbdaa90aa703	Amoxicillin Powder for Oral Suspension Rx Only 11/2009
52959-613-03	2019-11-13	C162847	48780-1	97449f38-d4ab-f6ea-e053-dbdaa90aa703	Amoxicillin Powder for Oral Suspension Rx Only 11/2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-613-02	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		1
52959-613-03	Amoxicillin	150 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	150		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-613-02	ML - Milliliter	52959-613	5dd3f182-f789-4b61-97dd-ec73a62534bf	1	2015-10-02
52959-613-03	ML - Milliliter	52959-613	9bb06536-a67d-4cb8-9919-9a6b205148fc	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-613	AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20111215_3e1df272-caf6-4247-8ccf-4e37bfe67e0a.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 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	60c7ae87-9631-4b29-9ca4-82fb3bafcab8	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	bd46de4c-4571-ba9a-e053-2a95a90a792d	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bce45db-dea7-4090-9d64-8b11b08d963e	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	0ce05282-995c-461e-b807-facb1fcbb405	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	9cad7ff5-5151-47d9-bc66-2ded25deefc2	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	54c1d2a4-fe96-6efb-e054-00144ff88e88	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	5b2a2e62-6fd2-4ab1-b936-8702e68233fa	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5c60cb1c-3baf-3af2-e053-2a91aa0ae208	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	0b5acc3f-c474-4b16-9d66-8048abb3b22d	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals Inc.	2177c68d-2884-ce70-e063-6294a90aa267	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	Proficient Rx LP	6a9cfa97-3715-4b75-a1e3-932a34a942d4	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	077f4a65-3cfb-4cb1-99f2-e27ffc5939c0	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	ca2886d0-7be7-4d41-bad5-df3ad44e0e7e	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6c7bccff-00bf-46b0-a9ee-eb27d38d7377	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322
Amoxicillin	AMOXICILLIN	Proficient Rx LP	9cac2bf2-fb48-4e83-b953-61c4d55f7e19	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065322 application number: ANDA065322

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	3e1df272-caf6-4247-8ccf-4e37bfe67e0a	1
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	3e1df272-caf6-4247-8ccf-4e37bfe67e0a	1
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	3e1df272-caf6-4247-8ccf-4e37bfe67e0a	1
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	3e1df272-caf6-4247-8ccf-4e37bfe67e0a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52959-613-02	52959061302	100 mL in 1 BOTTLE	100 ml	Historical
52959-613-03	52959061303	150 mL in 1 BOTTLE	150 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin Powder for Oral Suspension Rx Only 11/2009	H.J. Harkins Company, Inc. \| West-ward Pharmaceutical Corp \| Hikma Pharmaceutical	2011-10-10	HUMAN PRESCRIPTION DRUG LABEL	1