Amoxicillin

Product NDC: 10544-165
11-digit product format: 105440165
Labeler code: 10544
Product ID: 10544-165_ffabdb16-54db-4f3e-a818-4fc1162637a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA064013
Marketing category: ANDA
Marketing start: 2013-11-15
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-165		I	Inactivated by FDA	2026-08-11
excluded package	package	10544-165	10544-165-30	I	Inactivated by FDA	2026-08-11
excluded package	package	10544-165	10544-165-40	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 2 · 66 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	10544-165-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-165-30	`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	10544-165-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-165-30	`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	10544-165-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-165-30	`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	10544-165-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-165-30	`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	10544-165-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-165-30	`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	10544-165-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-165-30	`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	10544-165-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-165-30	`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	10544-165-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-165-30	`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	10544-165-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-165-30	`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	10544-165-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-165-30	`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	10544-165-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-165-30	`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	10544-165-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-165-30	`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	10544-165-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-165-30	`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	10544-165-40	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-165-30	`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	10544-165-40	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-165-30	`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	10544-165-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-165-30	`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	10544-165-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-165-30	`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	10544-165-40	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-165-30	`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	10544-165-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-165-30	`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	10544-165-40	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-165-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
A064013-001	AMOXICILLIN	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22
A064013-002	AMOXICILLIN	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A064013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064013-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064013-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064013-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064013-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064013-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064013-002	AB	1	`c0c555d07b60…`

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
10544-165-30	2020-01-31	C162847	48780-1	9d75b9d0-d117-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-res
10544-165-40	2020-01-31	C162847	48780-1	9d75b9d0-d117-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-165-30	Amoxicillin	30 in 1 BOTTLE	TABLET, CHEWABLE	30		3
10544-165-40	Amoxicillin	40 in 1 BOTTLE	TABLET, CHEWABLE	40		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-165	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3	Legacy NDC, 2 package rows	20150801_e91786c4-f928-4419-bd57-eca11498a6e6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	26e257d5-5b98-3795-e063-6394a90a05bc	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	98e9274c-c02e-44d9-8cc5-17536ef03a77	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Proficient Rx LP	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	63b395ca-f0ea-4429-b8aa-18f495596e4d	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013

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
598025	amoxicillin 250 MG Chewable Tablet	PSN	e91786c4-f928-4419-bd57-eca11498a6e6	3
598025	amoxicillin 250 MG Chewable Tablet	SCD	e91786c4-f928-4419-bd57-eca11498a6e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-165-30	10544016530	30 in 1 BOTTLE	Historical
10544-165-40	10544016540	40 in 1 BOTTLE	Historical