Amoxicillin

Product NDC: 68071-2604
11-digit product format: 680712604
Labeler code: 68071
Product ID: 68071-2604_d3c325a1-cdd7-b27c-e053-2a95a90aa534
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065334
Marketing category: ANDA
Marketing start: 2006-12-28
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 400 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2604		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2604	68071-2604-5	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2604-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2604-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2604-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2604-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2604-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2604-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2604-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2604-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2604-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2604-5	2025-01-30	C162847	48780-1	f386c64a-2889-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974
68071-2604-5	2023-07-14	C162847	48780-1	f386c64a-2889-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974
68071-2604-5	2023-01-30	C162847	48780-1	f386c64a-2889-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2604-5	Amoxicillin	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2604	AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20230715_d3c32596-2913-7a49-e053-2a95a90a00a0.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
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	d3c32596-2913-7a49-e053-2a95a90a00a0	2
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	d3c32596-2913-7a49-e053-2a95a90a00a0	2
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	d3c32596-2913-7a49-e053-2a95a90a00a0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2604-5	68071260405	75 mL in 1 BOTTLE (68071-2604-5)	75 ml	2021-12-22	0000-00-00	No	No	Current