Amoxicillin

Product NDC: 50090-6323
11-digit product format: 500906323
Labeler code: 50090
Product ID: 50090-6323_7b8e6d3c-f537-44d3-8c2a-c3dd07ff0f2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065334
Marketing category: ANDA
Marketing start: 2006-12-28
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 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
A065334-001	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2006-12-28
A065334-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065334-001	AB
A065334-002	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	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`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	A065334-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065334-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065334-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065334-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065334-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065334-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065334-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065334-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065334-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065334-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065334-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065334-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065334-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065334-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065334-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065334-002	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	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
3d8a700b-b23b-459a-a19a-213dd39b6a3a	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
50090-6323-0	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6323-0	ML - Milliliter	50090-6323	8b0e6d26-cea4-47cc-847f-8a22fc570eb6	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6323	AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	6	Current NDC, Legacy NDC, 1 package rows	20240501_3d8a700b-b23b-459a-a19a-213dd39b6a3a.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	2732a8c7-9e4b-43c9-9712-df4b237ab69c	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
AMOXICILLIN	AMOXICILLIN	DirectRx	cedde8f5-aadd-53de-e053-2995a90aab16	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	554239db-69fe-405a-910a-d9f9e3f8b6ed	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	97a657a3-8238-f5f1-e053-2a95a90a7a7a	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	3cacd754-73f4-496e-a529-9ca39fa6692d	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	d5ecb620-5267-4dcf-be81-64c7766516f5	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3d8a700b-b23b-459a-a19a-213dd39b6a3a	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334 ndc (product): 50090-6323
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
AMOXICILLIN	AMOXICILLIN	DIRECT RX	0173e9de-a995-4386-bb65-8fc2bbf347f9	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	fcdaba34-373f-4d4e-8203-76f02e3bb00a	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	d5eba477-e255-4d97-9e16-30543c298680	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e40f3e20-facf-46f4-89c7-3593bc27d0fc	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334

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	3d8a700b-b23b-459a-a19a-213dd39b6a3a	6
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	3d8a700b-b23b-459a-a19a-213dd39b6a3a	6
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	3d8a700b-b23b-459a-a19a-213dd39b6a3a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6323-0	50090632300	100 mL in 1 BOTTLE (50090-6323-0)	100 ml	2023-01-12	0000-00-00	No	No	Current