Amoxicillin

Product NDC: 43063-563
11-digit product format: 430630563
Labeler code: 43063
Product ID: 43063-563_dd7eccbe-ad04-e61d-e053-2995a90a068e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065271
Marketing category: ANDA
Marketing start: 2005-11-09
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 500 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-563		D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-06	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-08	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-09	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-14	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-15	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-21	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-28	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-30	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-40	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-56	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-60	D	Discontinued by firm	2026-08-03
excluded package	package	43063-563	43063-563-63	D	Discontinued by firm	2026-08-03

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 · 13 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	43063-563-60
excluded package	package	43063-563-28
excluded package	package	43063-563-21
excluded package	package	43063-563-40
excluded package	package	43063-563-56
excluded package	package	43063-563-06
excluded package	package	43063-563-63
excluded package	package	43063-563-08
excluded package	package	43063-563-15
excluded package	package	43063-563-30
excluded package	package	43063-563-09
excluded package	package	43063-563-14

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
A065271-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		2005-11-09
A065271-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / 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
A065271-001	AB
A065271-002	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	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / 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	A065271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065271-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065271-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065271-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065271-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065271-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065271-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065271-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065271-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065271-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065271-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065271-002	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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-563-06	EA - Each	43063-563	23822328-2019-4ae6-9373-b6acbf2c4659	1	2015-08-04
43063-563-08	EA - Each	43063-563	d01aa20f-8e40-4cdc-8d0a-30fcfcd65eb7	1	2016-03-04
43063-563-09	EA - Each	43063-563	b4230104-f0ee-4bda-8d5f-c7f42772dff6	1	2015-08-04
43063-563-14	EA - Each	43063-563	47f226d7-d75a-4fe3-a09f-5fc88c070686	1	2016-01-13
43063-563-15	EA - Each	43063-563	24690412-9f33-43da-80b5-5dfa3dccbfc2	1	2015-05-05
43063-563-21	EA - Each	43063-563	24410141-71a1-49a5-a61c-2d14cc6b7430	1	2015-04-03
43063-563-28	EA - Each	43063-563	45be1991-2c4c-4c0e-b176-c26e2711dc1d	1	2015-05-05
43063-563-30	EA - Each	43063-563	63aed9c6-5576-43d8-848f-d8ae6d4d5ee3	1	2015-04-03
43063-563-40	EA - Each	43063-563	93d92a48-6822-4a4e-bf34-108ba8d2d0e9	1	2015-04-03
43063-563-56	EA - Each	43063-563	e61d4522-691f-43a1-8b30-c8fc11e936ad	1	2016-03-04
43063-563-60	EA - Each	43063-563	ec45e6e2-9f21-4b2a-a948-b7786861bb24	1	2016-01-13
43063-563-63	EA - Each	43063-563	39461ff2-b685-4c0e-aab6-37a482f35a97	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-563	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	23	Legacy NDC	20240508_ef524ab0-00ae-4a1f-ba68-d425a6685935.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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	1d0d8bc4-137e-ef10-e063-6294a90acf62	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	53548597-347b-42a9-916c-e88cd27b8dcd	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ef03286b-4ba7-4952-9ab1-90cacf300504	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5155ca5d-fe58-42b4-e063-6394a90ab135	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin 500 mg	AMOXICILLIN	Health Department, Oklahoma State	f049551b-4708-eb13-e053-2a95a90afd1f	2025-12-13		Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	32b224c2-1354-4b58-b082-b93330e6962b	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	071086f5-e4ed-b1d9-e063-6294a90ad304	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bbaeb509-ad04-4668-a1db-4358038893f2	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271

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
308191	amoxicillin 500 MG Oral Capsule	PSN	b0523dc3-668f-466f-9421-2aae3b9b5751	3
308191	amoxicillin 500 MG Oral Capsule	SCD	b0523dc3-668f-466f-9421-2aae3b9b5751	3
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	b0523dc3-668f-466f-9421-2aae3b9b5751	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-563-06	43063056306	6 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-06)	6 capsule	2015-06-22	0000-00-00	No	No	Current
43063-563-08	43063056308	8 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-08)	8 capsule	2016-02-17	0000-00-00	No	No	Current
43063-563-09	43063056309	9 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-09)	9 capsule	2015-05-06	0000-00-00	No	No	Current
43063-563-14	43063056314	14 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-14)	14 capsule	2015-10-19	0000-00-00	No	No	Current
43063-563-15	43063056315	15 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-15)	15 capsule	2015-04-14	0000-00-00	No	No	Current
43063-563-21	43063056321	21 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-21)	21 capsule	2015-03-11	0000-00-00	No	No	Current
43063-563-28	43063056328	28 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-28)	28 capsule	2015-03-11	0000-00-00	No	No	Current
43063-563-30	43063056330	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-30)	30 capsule	2015-03-09	0000-00-00	No	No	Current
43063-563-40	43063056340	40 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-40)	40 capsule	2015-03-23	0000-00-00	No	No	Current
43063-563-56	43063056356	56 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-56)	56 capsule	2016-01-21	0000-00-00	No	No	Current
43063-563-60	43063056360	60 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-60)	60 capsule	2015-10-19	0000-00-00	No	No	Current
43063-563-63	43063056363	63 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-63)	63 capsule	2016-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	23
Amoxicillin - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2018-03-01	HUMAN PRESCRIPTION DRUG LABEL	3