Amoxicillin

Product NDC: 67296-0986
Requested package NDC: 67296-0986-4
11-digit product format: 672960986
Labeler code: 67296
Product ID: 67296-0986_d60f72c2-0104-287c-e053-2995a90a5960
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA065291
Marketing category: ANDA
Marketing start: 2007-03-01
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0986	67296-0986-4	I	Inactivated by FDA		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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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, Related label table
NDC	Effective	Related label
67296-0986-2	2026-01-29	Amoxicillin 500mg
67296-0986-3	2026-01-29	Amoxicillin 500mg
67296-0986-4	2026-01-29	Amoxicillin 500mg
67296-0986-5	2026-01-29	Amoxicillin 500mg
67296-0986-6	2026-01-29	Amoxicillin 500mg
67296-0986-2	2024-07-11	Amoxicillin 500mg
67296-0986-3	2024-07-11	Amoxicillin 500mg
67296-0986-4	2024-07-11	Amoxicillin 500mg
67296-0986-5	2024-07-11	Amoxicillin 500mg
67296-0986-6	2024-07-11	Amoxicillin 500mg
67296-0986-2	2024-01-30	Amoxicillin 500mg
67296-0986-3	2024-01-30	Amoxicillin 500mg
67296-0986-4	2024-01-30	Amoxicillin 500mg
67296-0986-5	2024-01-30	Amoxicillin 500mg
67296-0986-6	2024-01-30	Amoxicillin 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0986-2	Amoxicillin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	5
67296-0986-3	Amoxicillin	3 in 1 BOTTLE, PLASTIC	CAPSULE	3	5
67296-0986-4	Amoxicillin	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	5
67296-0986-5	Amoxicillin	21 in 1 BOTTLE, PLASTIC	CAPSULE	21	5
67296-0986-6	Amoxicillin	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0986	AMOXICILLIN CAPSULE [REDPHARM DRUG, INC.]	5	Legacy NDC, 5 package rows	20240712_a61e4152-48e9-6b40-e053-2995a90a6aad.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308191	amoxicillin 500 MG Oral Capsule	PSN	a61e4152-48e9-6b40-e053-2995a90a6aad	5
308191	amoxicillin 500 MG Oral Capsule	SCD	a61e4152-48e9-6b40-e053-2995a90a6aad	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	a61e4152-48e9-6b40-e053-2995a90a6aad	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0986-4	67296098604	40 CAPSULE in 1 BOTTLE, PLASTIC (67296-0986-4)	40 capsule	2020-01-01	0000-00-00	No	No	Current