Amoxicillin

Product NDC: 59115-046
11-digit product format: 591150046
Labeler code: 59115
Product ID: 59115-046_43603a64-325c-4c5a-b7c4-4b06d15b8c9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Hikma Pharmaceutical
Application: ANDA065322
Marketing category: ANDA
Marketing start: 2006-06-19
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 125 mg/5mL
Pharmacologic classes: Penicillin-clas
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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…`

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