Amoxicillin

Product NDC: 10544-434
11-digit product format: 105440434
Labeler code: 10544
Product ID: 10544-434_1ec9a16b-d696-1d4e-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA065255
Marketing category: ANDA
Marketing start: 2014-02-07
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-434		I	Inactivated by FDA	2026-08-17
excluded package	package	10544-434	10544-434-14	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-434	10544-434-20	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 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	10544-434-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-434-14	`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	10544-434-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-434-14	`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	10544-434-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-434-14	`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	10544-434-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-434-14	`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	10544-434-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-434-14	`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	10544-434-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-434-14	`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	10544-434-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-434-14	`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	10544-434-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-434-14	`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	10544-434-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-434-14	`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	10544-434-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-434-14	`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	10544-434-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-434-14	`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	10544-434-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-434-14	`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	10544-434-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-434-14	`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	10544-434-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-434-14	`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	10544-434-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-434-14	`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	10544-434-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-434-14	`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	10544-434-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-434-14	`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	10544-434-20	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-434-14	`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	10544-434-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-434-14	`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	10544-434-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-434-14	`e2bbac7714bc…`	`27bdfed8d636…`

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
10544-434-14	2020-01-31	C162847	48780-1	9d75b9d0-4da4-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use, see full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
10544-434-20	2020-01-31	C162847	48780-1	9d75b9d0-4da4-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use, see full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-434-14	Amoxicillin	14 in 1 BOTTLE	TABLET, COATED	14		5
10544-434-20	Amoxicillin	20 in 1 BOTTLE	TABLET, COATED	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-434-20	EA - Each	10544-434	eef0274d-90c8-4087-a025-3774537cb14e	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-434	AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]	5	Legacy NDC, 2 package rows	20150903_0fc675ec-e756-274e-e054-00144ff88e88.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	0fc675ec-e756-274e-e054-00144ff88e88	5
308194	amoxicillin 875 MG Oral Tablet	SCD	0fc675ec-e756-274e-e054-00144ff88e88	5
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	0fc675ec-e756-274e-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-434-14	10544043414	14 in 1 BOTTLE	Historical
10544-434-20	10544043420	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin - Blenheim Pharmacal, Inc.	Blenheim Pharmacal, Inc.	2015-09-02	HUMAN PRESCRIPTION DRUG LABEL	5