AMOXICILLIN

Product NDC: 81964-350
11-digit product format: 819640350
Labeler code: 81964
Product ID: 81964-350_5253eb61-6d82-8057-e063-6294a90a5c84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: USAntibiotics, LLC
Application: ANDA062216
Marketing category: ANDA
Marketing start: 2025-05-15
Substance: AMOXICILLIN
Active strength: 500 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062216-001	AMOXIL	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A062216-004	AMOXIL	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062216-001	AB
A062216-004	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A062216-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062216-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062216-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062216-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062216-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062216-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062216-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062216-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062216-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062216-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062216-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062216-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062216-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062216-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062216-004	AB	1	`74a2ff9319b5…`

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	500 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308182	Internal RxNorm lookup
308191	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
110ba6b1-f175-48a1-8e30-616c02212538	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	SPL version
81964-350-10	AMOXICILLIN	100 in 1 BOTTLE	CAPSULE	100	5
81964-350-60	AMOXICILLIN	60 in 1 BOTTLE	CAPSULE	60	5
81964-350-98	AMOXICILLIN	8 in 1 PAIL	CAPSULE	8	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81964-350	AMOXICILLIN CAPSULE [USANTIBIOTICS, LLC]	5	Current NDC, 3 package rows	20250528_110ba6b1-f175-48a1-8e30-616c02212538.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	REMEDYREPACK INC.	4adc198e-39d8-4b3e-bfa4-278aaf4064ae	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	5a660370-9a81-33f9-e063-6394a90a6c62	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	USAntibiotics, LLC	110ba6b1-f175-48a1-8e30-616c02212538	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216 ndc (product): 81964-350
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	0a100e76-513c-98d3-e063-6294a90adf47	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216

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
308182	amoxicillin 250 MG Oral Capsule	PSN	110ba6b1-f175-48a1-8e30-616c02212538	5
308191	amoxicillin 500 MG Oral Capsule	PSN	110ba6b1-f175-48a1-8e30-616c02212538	5
308182	amoxicillin 250 MG Oral Capsule	SCD	110ba6b1-f175-48a1-8e30-616c02212538	5
308191	amoxicillin 500 MG Oral Capsule	SCD	110ba6b1-f175-48a1-8e30-616c02212538	5
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	110ba6b1-f175-48a1-8e30-616c02212538	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	110ba6b1-f175-48a1-8e30-616c02212538	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81964-350-10	81964035010	100 CAPSULE in 1 BOTTLE (81964-350-10)	100 capsule	2025-05-15	No	No	Current
81964-350-60	81964035060	60 CAPSULE in 1 BOTTLE (81964-350-60)	60 capsule	2025-05-15	No	No	Current
81964-350-98	81964035098	8 CAPSULE in 1 PAIL (81964-350-98)	8 capsule	2025-05-15	No	No	Current