Amoxil

Product NDC: 72189-385
11-digit product format: 721890385
Labeler code: 72189
Product ID: 72189-385_2c4cbe6c-c27d-15fe-e063-6294a90ac409
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin Oral Susp
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: DirectRx
Application: ANDA065325
Marketing category: ANDA
Marketing start: 2022-10-21
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-385-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-385-32	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065325-001	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19
A065325-002	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065325-001	AB
A065325-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065325-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065325-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065325-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065325-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065325-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065325-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065325-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065325-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065325-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065325-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065325-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065325-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065325-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065325-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065325-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065325-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065325-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065325-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxil
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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ec7dd735-dc92-3d29-e053-2a95a90af549	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
72189-385-32	Amoxil	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-385-32	ML - Milliliter	72189-385	d535a542-9d66-4a22-a5a2-01a908debec2	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-385	AMOXIL (AMOXICILLIN ORAL SUSP) POWDER, FOR SUSPENSION [DIRECTRX]	3	Current NDC, Legacy NDC, 1 package rows	20250123_ec7dd735-dc92-3d29-e053-2a95a90af549.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	afef7c71-2d19-41ed-9213-b32ccc1bf1d3	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c0e333d9-164d-4196-b5f5-929993d1c3c2	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	992d7829-34d1-4c88-8a5c-1a92d001d194	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxil	AMOXICILLIN ORAL SUSP	DirectRx	ec7dd735-dc92-3d29-e053-2a95a90af549	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 72189-385
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	59a546ed-84b7-a54a-e053-2991aa0a3a0d	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8398f2c9-37ca-9b59-e053-2991aa0a2c11	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	156ef8e9-b6e4-4512-865f-7139c90c8f9b	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	77265bcd-c05d-443a-84c4-6e5ac75ee42c	2023-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Proficient Rx LP	756545f1-77af-49a0-a697-4cced31711d4	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-385-32	72189038532	100 mL in 1 BOTTLE (72189-385-32)	100 ml	2022-10-21	0000-00-00	No	No	Current