Amoxicillin

Product NDC: 53002-0130
11-digit product format: 530020130
Labeler code: 53002
Product ID: 53002-0130_fa2f883d-0237-4370-9a26-eaad3ee367e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA065256
Marketing category: ANDA
Marketing start: 2005-11-09
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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-0130		I	Inactivated by FDA	2026-08-11
excluded package	package	53002-0130	53002-0130-1	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-0130	53002-0130-2	I	Inactivated by FDA	2026-08-11

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0130-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-0130-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0130-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-0130-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0130-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-0130-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0130-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-0130-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0130-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-0130-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0130-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-0130-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0130-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-0130-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0130-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-0130-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0130-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-0130-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-0130-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-0130-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-0130-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-0130-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A065256-001	AMOXICILLIN	AMOXICILLIN	500MG	TABLET / ORAL	AB		2005-11-09
A065256-002	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB		2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065256-001	AB
A065256-002	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	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`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	A065256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065256-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065256-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065256-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065256-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065256-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065256-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065256-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065256-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065256-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065256-002	AB	1	`782e0a99824c…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-0130-1	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-2	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-1	2023-06-07	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-2	2023-06-07	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-1	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-2	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-1	2020-12-16	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-2	2020-12-16	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-1	2020-01-31	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-2	2020-01-31	These highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-0130-1	Amoxicillin	14 in 1 BOTTLE	TABLET, FILM COATED	14		6
53002-0130-2	Amoxicillin	20 in 1 BOTTLE	TABLET, FILM COATED	20		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-0130	AMOXICILLIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	6	Legacy NDC, 2 package rows	20230609_15906fc2-67ce-4c7e-abc9-73bd1d9f5498.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Coupler LLC	5827b6de-6b48-d73a-e063-6394a90a4a72	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	a2c91cf0-a4e4-44c0-b712-bee63dd6c22b	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	9618d038-e880-47f6-b8d7-bbf8ab35364d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	f37eb415-77b2-41b0-8d20-64e821e4b05d	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Proficient Rx LP	313ea909-5b1b-41ff-a0db-5aadc12e2e4f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Coupler LLC	5037e2a5-52e9-caec-e063-6294a90ad837	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	American Health Packaging	d339ea0f-8797-460f-a3b7-b8455c250366	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	4b23e6f5-9287-4c01-b795-b8c538833039	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	f1eee459-9021-b26e-e053-2995a90a7291	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	QPharma, Inc.	2700df91-c5ef-4931-9ad7-a3c1c146ccac	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8e6f9df1-0754-69e4-e053-2a95a90acc49	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	3e4f0f03-438b-ddfb-e063-6294a90adb38	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	3880b9c2-62a5-0d23-e063-6394a90a1252	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	b91f40dd-40db-473d-a399-166aeb1ce7e2	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	aaf42367-153e-4525-af5f-f5f1c7d6c559	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bef50f2a-78c6-4d0c-8ad9-cfa3c801629d	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	963986fc-0e59-21b0-e053-2a95a90a9531	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	c3d3f94f-e976-4625-9667-3d716932f2fa	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	20eb4ade-f3b8-db66-e063-6294a90ae846	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256

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	15906fc2-67ce-4c7e-abc9-73bd1d9f5498	6
308194	amoxicillin 875 MG Oral Tablet	SCD	15906fc2-67ce-4c7e-abc9-73bd1d9f5498	6
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	15906fc2-67ce-4c7e-abc9-73bd1d9f5498	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-0130-1	53002013001	14 TABLET, FILM COATED in 1 BOTTLE (53002-0130-1)	2017-10-01	0000-00-00	No	No	Current
53002-0130-2	53002013002	20 TABLET, FILM COATED in 1 BOTTLE (53002-0130-2)	2017-10-01	0000-00-00	No	No	Current