Amoxicillin

Product NDC: 59115-041
11-digit product format: 591150041
Labeler code: 59115
Product ID: 59115-041_16871538-91a1-49ab-827d-8ca31a9dd593
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceutical
Application: ANDA065291
Marketing category: ANDA
Marketing start: 2007-02-05
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 500 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

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…`

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59115-041-01	59115004101	100 CAPSULE in 1 BOTTLE (59115-041-01)	100 capsule	2007-02-05	0000-00-00	No	No	Current
59115-041-22	59115004122	20 CAPSULE in 1 BOTTLE (59115-041-22)	20 capsule	2007-02-05	0000-00-00	No	No	Current
59115-041-55	59115004155	500 CAPSULE in 1 BOTTLE (59115-041-55)	500 capsule	2007-02-05	0000-00-00	No	No	Current