Amoxicillin

Product NDC: 45865-594
Requested package NDC: 45865-594-20
11-digit product format: 458650594
Labeler code: 45865
Product ID: 45865-594_9adc29d7-203d-24be-e053-2995a90a9c29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA065228
Marketing category: ANDA
Marketing start: 2005-07-13
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	45865-594	45865-594-20	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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A065228-001	AMOXICILLIN	AMOXICILLIN	500MG	TABLET / ORAL	AB		2005-07-13
A065228-002	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB		2005-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065228-001	AB
A065228-002	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	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`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	A065228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065228-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065228-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065228-002	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-594-20	2023-01-30	C162847	48780-1	f386c64a-4835-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-594-20	Amoxicillin	20 in 1 BOTTLE	TABLET, FILM COATED	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-594	AMOXICILLIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20191230_9adc29c6-79e0-3ede-e053-2a95a90a6721.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	ad804b34-169c-44bf-a469-f1149433d96b	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228
Amoxicillin	AMOXICILLIN	Direct_Rx	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7974a666-6d1d-446b-8ea5-f7145dc66358	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065228 application number: ANDA065228

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
308194	amoxicillin 875 MG Oral Tablet	PSN	9adc29c6-79e0-3ede-e053-2a95a90a6721	1
308194	amoxicillin 875 MG Oral Tablet	SCD	9adc29c6-79e0-3ede-e053-2a95a90a6721	1
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	9adc29c6-79e0-3ede-e053-2a95a90a6721	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-594-20	45865059420	20 TABLET, FILM COATED in 1 BOTTLE (45865-594-20)	2018-12-12	0000-00-00	No	No	Current