Amoxicillin

Product NDC: 68071-3925
Requested package NDC: 68071-3925-1
11-digit product format: 680713925
Labeler code: 68071
Product ID: 68071-3925_4528faa7-3b08-a65e-e063-6394a90aa52c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: NDA050760
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-04-01
Substance: AMOXICILLIN
Active strength: 400 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N050760-001	AMOXIL	AMOXICILLIN	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15
N050760-002	AMOXIL	AMOXICILLIN	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050760-002	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 · 86 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
2026-09-14 22:38:34	2026-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050760-001	AMOXIL	200MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050760-002	AMOXIL	400MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050760-001	AMOXIL	200MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050760-002	AMOXIL	400MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050760-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050760-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050760-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050760-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050760-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050760-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050760-002	AB	1	`a50c72e98297…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	400 mg/5mL

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
308189	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
4528f48d-5bda-b307-e063-6294a90a294c	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
68071-3925-1	Amoxicillin	100 mL in 1 BOTTLE	FOR SUSPENSION	100		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	USAntibiotics, LLC	06e5c07d-d95c-4955-8d35-a4703ca2359e	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760
Amoxicillin	AMOXICILLIN	ASCLEMED USA INC.	08100595-e6de-4a8a-a177-a94f849bbe9f	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4528f48d-5bda-b307-e063-6294a90a294c	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760 ndc (package): 68071-3925-1 ndc (product): 68071-3925 ndc11 (package): 68071392501

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
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	4528f48d-5bda-b307-e063-6294a90a294c	1
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	4528f48d-5bda-b307-e063-6294a90a294c	1
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	4528f48d-5bda-b307-e063-6294a90a294c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3925-1	68071392501	100 mL in 1 BOTTLE (68071-3925-1)	100 ml	2025-12-04	No	No	Current