Amoxicillin

Product NDC: 68788-4062
Requested package NDC: 68788-4062-2
11-digit product format: 687884062
Labeler code: 68788
Product ID: 68788-4062_6a3f7e6c-fec2-41da-a070-00a02e64c920
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA065255
Marketing category: ANDA
Marketing start: 2026-01-28
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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 · 43 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	A065255-001	AMOXICILLIN	875MG	TABLET / ORAL	AB	2006-03-29	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A065255-001	AB	1	`84e616aacf4f…`
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…`

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: 2027-12-31

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
6a3f7e6c-fec2-41da-a070-00a02e64c920	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
68788-4062-2	Amoxicillin	20 in 1 BOTTLE	TABLET, COATED	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4062-2	EA - Each	68788-4062	14af4d00-6569-4551-9685-6d6f79e1f17a	1	2026-03-17

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	Redpharm Drug	5a79669f-52f7-e8ea-e063-6394a90a93b8	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065255 application number: ANDA065255
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 ndc (package): 68788-4062-2 ndc (product): 68788-4062 ndc11 (package): 68788406202
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	6a3f7e6c-fec2-41da-a070-00a02e64c920	1
308194	amoxicillin 875 MG Oral Tablet	SCD	6a3f7e6c-fec2-41da-a070-00a02e64c920	1
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	6a3f7e6c-fec2-41da-a070-00a02e64c920	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-4062-2	68788406202	20 TABLET, COATED in 1 BOTTLE (68788-4062-2)	2026-01-28	No	No	Current