Amoxicillin

Product NDC: 76420-573
Requested package NDC: 76420-573-15
11-digit product format: 764200573
Labeler code: 76420
Product ID: 76420-573_fe4d14a5-07d5-9345-e053-6294a90a78b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA061931
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: AMOXICILLIN
Active strength: 250 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A061931-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982
A061931-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982
A061931-003	AMOXICILLIN PEDIATRIC	AMOXICILLIN	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061931-002	AB
A061931-003	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 4 · 129 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	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`301d65b070ca…`

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	A061931-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061931-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061931-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061931-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061931-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061931-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061931-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061931-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061931-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061931-003	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	250 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
239191	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
bfd67724-fb22-4eac-8ebd-555614c16329	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
76420-573-10	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	1
76420-573-15	Amoxicillin	150 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	150	1
76420-573-80	Amoxicillin	80 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	80	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-573-10	ML - Milliliter	76420-573	1795964e-2130-426e-8685-d759306b87a8	1	2023-10-16
76420-573-15	ML - Milliliter	76420-573	d71448d5-d401-46cb-8fdd-702a8dccf7ee	1	2023-10-16
76420-573-80	ML - Milliliter	76420-573	4d50d5eb-3374-432d-8342-32d87dbe8751	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-573	AMOXICILLIN POWDER, FOR SUSPENSION [ASCLEMED USA, INC.]	1	Current NDC, 3 package rows	20230618_bfd67724-fb22-4eac-8ebd-555614c16329.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	cf707c13-3b40-079c-e053-2995a90a2176	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5780c9e4-5e22-270c-e053-2a91aa0a36ba	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	bfd67724-fb22-4eac-8ebd-555614c16329	2023-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931 ndc (package): 76420-573-15 ndc (product): 76420-573 ndc11 (package): 76420057315
Amoxicillin	AMOXICILLIN	Proficient Rx LP	de792ac6-4b3d-4d34-8e50-030b5bd830d7	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931

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
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	bfd67724-fb22-4eac-8ebd-555614c16329	1
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	bfd67724-fb22-4eac-8ebd-555614c16329	1
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	bfd67724-fb22-4eac-8ebd-555614c16329	1
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	bfd67724-fb22-4eac-8ebd-555614c16329	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-573-15	76420057315	150 mL in 1 BOTTLE (76420-573-15)	150 ml	2023-06-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-06-17	HUMAN PRESCRIPTION DRUG LABEL	1