Amoxicillin

Product NDC: 53002-2090
Requested package NDC: 53002-2090-1
11-digit product format: 530022090
Labeler code: 53002
Product ID: 53002-2090_1bec764a-9031-406d-9840-745732975b38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA065387
Marketing category: ANDA
Marketing start: 2007-03-26
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-2090	53002-2090-1	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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A065387-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26
A065387-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065387-001	AB
A065387-002	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	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`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	A065387-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065387-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065387-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065387-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065387-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065387-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065387-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065387-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065387-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065387-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065387-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065387-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065387-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065387-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065387-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065387-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065387-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065387-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065387-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065387-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065387-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065387-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065387-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065387-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065387-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065387-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065387-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065387-002	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-2090-1	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-2	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-3	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-1	2023-06-08	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-2	2023-06-08	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-3	2023-06-08	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-1	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-2	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-3	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-1	2020-12-15	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-2	2020-12-15	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-3	2020-12-15	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-1	2020-01-31	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-2	2020-01-31	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974
53002-2090-3	2020-01-31	These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension. AMOXICILLIN Capsules, Tablets, and Oral Suspension, for oral administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-2090-1	Amoxicillin	80 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	80	8
53002-2090-2	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	8
53002-2090-3	Amoxicillin	150 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	150	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2090	AMOXICILLIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 3 package rows	20230609_196b4f19-c965-4c88-ab15-3705c2ccef74.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	HAWAII REPACK, INC.	669a243e-249d-4ccb-9693-66de073e53bb	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals, Inc.	88e76bdd-39f2-48c4-91ca-609511afd382	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8dba39df-5df8-31aa-e053-2a95a90adae1	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76f315c4-acbc-76c1-e053-2a91aa0aebcd	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bac30bb-1dbc-41de-ad50-0a1883f96198	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Proficient Rx LP	7f75de78-2228-48e0-8405-bf631ca431ab	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e4bd448e-7911-4ae3-b136-a66d13e2ebed	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065387 application number: ANDA065387

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	196b4f19-c965-4c88-ab15-3705c2ccef74	8
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	196b4f19-c965-4c88-ab15-3705c2ccef74	8
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	196b4f19-c965-4c88-ab15-3705c2ccef74	8
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	196b4f19-c965-4c88-ab15-3705c2ccef74	8
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	196b4f19-c965-4c88-ab15-3705c2ccef74	8
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	196b4f19-c965-4c88-ab15-3705c2ccef74	8
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	196b4f19-c965-4c88-ab15-3705c2ccef74	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2090-1	53002209001	80 mL in 1 BOTTLE (53002-2090-1)	80 ml	2018-10-01	0000-00-00	No	No	Current