Amoxicillin

Product NDC: 50090-6351
11-digit product format: 500906351
Labeler code: 50090
Product ID: 50090-6351_a4c80021-7610-435c-bbc3-f285ea3ff088
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204030
Marketing category: ANDA
Marketing start: 2014-09-15
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 42.

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
A204030-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2014-09-15
A204030-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2014-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204030-001	AB
A204030-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204030-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204030-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2014-09-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204030-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204030-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204030-002	AB	1	`bb7c543d1eb4…`

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
6a3d1af5-6e93-4f06-8d82-1c87290c46aa	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
50090-6351-0	Amoxicillin	150 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	150		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6351-0	ML - Milliliter	50090-6351	93fbb742-c780-402a-a398-c907e73ad9ce	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6351	AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	4	Current NDC, 1 package rows	20240501_6a3d1af5-6e93-4f06-8d82-1c87290c46aa.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	c19b533a-907a-6350-e053-2a95a90a1244	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	Proficient Rx LP	c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	234d0dfc-cb24-413f-b798-129c73eb848e	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	14a5f8c2-fdaf-4ad4-982b-c5aa128e242d	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	7db086c6-a56b-4848-9eec-abaaff9f5b6f	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	a2a5bb34-671b-499c-b8b4-c40fb51af09a	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	efc66d77-1733-41e1-9aed-7c10a4b4ba96	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204030 application number: ANDA204030 ndc (product): 50090-6351

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	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	4
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	4
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	4
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6351-0	50090635100	150 mL in 1 BOTTLE (50090-6351-0)	150 ml	2023-01-27	No	No	Current