Amoxicillin

Product NDC: 72189-463
Requested package NDC: 72189-463-20
11-digit product format: 721890463
Labeler code: 72189
Product ID: 72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA065228
Marketing category: ANDA
Marketing start: 2023-04-17
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-463	72189-463-20	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-463	72189-463-20	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A065228-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065228-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-07-13	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065228-002	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	875 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308194	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f98c49a3-e6bb-7fc7-e053-6394a90a9062	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-463-20	Amoxicillin	20 in 1 BOTTLE	TABLET, FILM COATED	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-463-20	EA - Each	72189-463	45c7603c-ad35-40a6-913a-342106ebf58e	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-463	AMOXICILLIN TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_f98c49a3-e6bb-7fc7-e053-6394a90a9062.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 ndc (package): 72189-463-20 ndc (product): 72189-463 ndc11 (package): 72189046320
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	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2
308194	amoxicillin 875 MG Oral Tablet	SCD	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	f98c49a3-e6bb-7fc7-e053-6394a90a9062	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-463-20	72189046320	20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)	2023-04-17	No	No	Current