Amoxicillin

Product NDC: 67296-0628
11-digit product format: 672960628
Labeler code: 67296
Product ID: 67296-0628_a11bffa2-a62e-467f-819c-bbabe82bb568
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: RedPharm Drug Inc.
Application: ANDA065255
Marketing category: ANDA
Marketing start: 2006-03-29
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-0628		I	Inactivated by FDA		2026-08-17
excluded package	package	67296-0628	67296-0628-1	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-0628-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-0628-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-0628-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-0628-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-0628-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-0628-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-0628-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-0628-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-0628-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-0628-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-0628-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0628-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0628-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0628-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0628-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67296-0628-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67296-0628-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67296-0628-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67296-0628-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67296-0628-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67296-0628-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-0628-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065255-001	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / ORAL	AB		2006-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065255-001	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 2 · 42 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	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A065255-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065255-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065255-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065255-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065255-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065255-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065255-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065255-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065255-001	AB	1	`e64feba35796…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
67296-0628-1	2019-10-29	C162847	48780-1	960f7f55-cac7-8e05-e053-dbdaa90a074a	AMOXICILLIN TABLETS, USP 875 mg Rx only Revised: August 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0628-1	Amoxicillin	20 in 1 BOTTLE	TABLET, COATED	20		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0628	AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]	2	Legacy NDC, 1 package rows	20110706_01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa.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	Preferred Pharmaceuticals Inc.	6a3f7e6c-fec2-41da-a070-00a02e64c920	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	b397d4be-d2ef-419a-98ac-844069c99d56	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	Proficient Rx LP	577d8a00-c538-4089-b788-01b4b92d22f2	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	05b9b595-05d9-469f-82a3-c2bc94c50be2	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	26469497-14c2-adb2-e063-6394a90af30a	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	85721bc3-37eb-4db6-8a40-8a1412ac953a	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	c8591c2a-92ef-4432-b19a-bb46063047ee	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4eee2b38-ca84-421d-87e1-031bc5a3f3a7	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	23b7a1fe-4e23-44ec-bc51-5209427c88ce	2022-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255

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	01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa	2
308194	amoxicillin 875 MG Oral Tablet	SCD	01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa	2
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67296-0628-1	67296062801	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN TABLETS, USP 875 mg Rx only Revised: August 2008	RedPharm Drug Inc. \| Hikma Pharmaceutical	2011-07-01	HUMAN PRESCRIPTION DRUG LABEL	2