Amoxicillin and Clavulanate Potassium

Product NDC: 68788-8318
11-digit product format: 687888318
Labeler code: 68788
Product ID: 68788-8318_2c966f10-3845-4fa9-aa1f-c56e7a671252
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA201090
Marketing category: ANDA
Marketing start: 2022-12-23
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 400; 57 mg/5mL; mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2011-12-20
A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201090-001	AB
A201090-002	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	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201090-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201090-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`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	A201090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201090-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201090-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201090-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201090-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201090-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201090-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201090-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201090-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201090-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201090-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201090-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201090-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201090-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201090-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201090-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201090-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201090-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201090-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201090-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201090-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201090-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201090-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201090-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201090-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201090-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201090-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201090-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201090-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201090-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate Potassium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	400 mg/5mL
CLAVULANATE POTASSIUM	57 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup
Q42OMW3AT8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617430	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
618953a3-0256-42ce-9155-d35325f017aa	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
ebb3e917-326a-9e18-0354-a19c9f63a2f3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8318-1	Amoxicillin and Clavulanate Potassium	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8318-1	ML - Milliliter	68788-8318	000eabf6-50e5-4aa8-97df-8c4d633c394a	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8318	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250126_618953a3-0256-42ce-9155-d35325f017aa.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	HAWAII REPACK, INC.	7fb0f56e-c098-49e4-b075-2eb8936582aa	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	ce488c24-2ec5-4d1b-b446-90f2497aa15d	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ca664448-12fb-0c6f-e053-2995a90a262c	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	618953a3-0256-42ce-9155-d35325f017aa	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090 ndc (product): 68788-8318
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	30446852-9a54-4d16-ba12-56ffd0149985	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	77126eee-9534-4e80-9d11-ec78ec66c826	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	30144e2e-d336-8fa3-e063-6394a90a6068	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin/Clav Pot Oral Susp	AMOXICILLIN/CLAV POT ORAL SUSP	Direct_Rx	e5bd9918-b073-c50b-e053-2a95a90aaeb7	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	abbebdc1-4410-76af-e053-2a95a90acb9c	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	fc5dc69a-3c23-49fc-b80f-1412aebc9b76	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	aad174d9-2c46-49aa-9a62-61063f405c53	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	f0a6d21d-203f-4fde-b010-a2730b86b491	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	ab1dbe70-696f-4ff9-a0c7-7406bff590ae	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	2718248d-d948-466e-959b-1a972519f108	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	4937611d-bd61-4538-ad1e-bd67e9527955	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	61f9224b-a91b-4154-a7f3-22c14601230f	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201090 application number: ANDA201090

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617430	amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension	PSN	618953a3-0256-42ce-9155-d35325f017aa	5
617430	amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension	SCD	618953a3-0256-42ce-9155-d35325f017aa	5
617430	amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension	SY	618953a3-0256-42ce-9155-d35325f017aa	5
617430	amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension	SY	618953a3-0256-42ce-9155-d35325f017aa	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8318-1	68788831801	100 mL in 1 BOTTLE (68788-8318-1)	100 ml	2022-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	5