Amoxicillin and Clavulanate Potassium

Product NDC: 0093-8675
11-digit product format: 000938675
Labeler code: 0093
Product ID: 0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA065162
Marketing category: ANDA
Marketing start: 2004-09-23
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 600; 42.9 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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065162-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065162-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	2004-03-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065162-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065162-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065162-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065162-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065162-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065162-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065162-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065162-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065162-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065162-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065162-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065162-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065162-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065162-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065162-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065162-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065162-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065162-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065162-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065162-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065162-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065162-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065162-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065162-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065162-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065162-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065162-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065162-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065162-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065162-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065162-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065162-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065162-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065162-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065162-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065162-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065162-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065162-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065162-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065162-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	600 mg/5mL
CLAVULANATE POTASSIUM	42.9 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
617993	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
e83f43dd-f79e-4166-9bee-9427e235c876	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
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
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	SPL version
0093-8675-74	Amoxicillin and Clavulanate Potassium	200 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	200	19
0093-8675-75	Amoxicillin and Clavulanate Potassium	125 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	125	19
0093-8675-78	Amoxicillin and Clavulanate Potassium	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-8675-74	ML - Milliliter	0093-8675	81b6b568-9e78-46e5-82ea-2d45f7495f82	1	2012-07-24
0093-8675-75	ML - Milliliter	0093-8675	c765f5b4-9422-4609-9a8a-499b78225701	1	2012-07-24
0093-8675-78	ML - Milliliter	0093-8675	15394cfb-1c11-4c26-a54f-8c9a48e8afba	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-8675	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20250216_e83f43dd-f79e-4166-9bee-9427e235c876.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 · 3 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	Chartwell RX, LLC	00b86913-50c8-443f-8467-f4f499d358af	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065162 application number: ANDA065162
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Teva Pharmaceuticals USA, Inc.	e83f43dd-f79e-4166-9bee-9427e235c876	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065162 application number: ANDA065162 ndc (product): 0093-8675
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	3a7248ca-2855-433e-aabc-42f0bb0db118	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065162 application number: ANDA065162

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
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	e83f43dd-f79e-4166-9bee-9427e235c876	19
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	e83f43dd-f79e-4166-9bee-9427e235c876	19
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	e83f43dd-f79e-4166-9bee-9427e235c876	19
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	e83f43dd-f79e-4166-9bee-9427e235c876	19
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	3a7248ca-2855-433e-aabc-42f0bb0db118	7
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	3a7248ca-2855-433e-aabc-42f0bb0db118	7
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	3a7248ca-2855-433e-aabc-42f0bb0db118	7
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	3a7248ca-2855-433e-aabc-42f0bb0db118	7
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	6c4b2675-6b23-4364-90fa-10aee45d3270	5
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	6c4b2675-6b23-4364-90fa-10aee45d3270	5
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	6c4b2675-6b23-4364-90fa-10aee45d3270	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	6c4b2675-6b23-4364-90fa-10aee45d3270	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	6c54661e-e530-424d-8d5d-4690c4df0b41	3
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	6c54661e-e530-424d-8d5d-4690c4df0b41	3
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	6c54661e-e530-424d-8d5d-4690c4df0b41	3
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	6c54661e-e530-424d-8d5d-4690c4df0b41	3
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	9adcc6d3-28bf-32d2-e053-2995a90a24a1	1
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	0f8b17fd-a8bd-433b-8e25-8c8903f8e6b0	1
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	9adcc6d3-28bf-32d2-e053-2995a90a24a1	1
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	0f8b17fd-a8bd-433b-8e25-8c8903f8e6b0	1
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	9adcc6d3-28bf-32d2-e053-2995a90a24a1	1
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	0f8b17fd-a8bd-433b-8e25-8c8903f8e6b0	1
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	9adcc6d3-28bf-32d2-e053-2995a90a24a1	1
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	0f8b17fd-a8bd-433b-8e25-8c8903f8e6b0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-8675-74	00093867574	200 mL in 1 BOTTLE (0093-8675-74)	200 ml	2004-09-23	0000-00-00	No	No	Current
0093-8675-75	00093867575	125 mL in 1 BOTTLE (0093-8675-75)	125 ml	2004-09-23	0000-00-00	No	No	Current
0093-8675-78	00093867578	75 mL in 1 BOTTLE (0093-8675-78)	75 ml	2004-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Teva Pharmaceuticals USA, Inc.	2024-12-01	HUMAN PRESCRIPTION DRUG LABEL	19
Amoxicillin and Clavulanate Potassium	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2023-03-14	HUMAN PRESCRIPTION DRUG LABEL	7
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2022-08-02	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin and Clavulanate Potassium	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	7
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaeuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin and Clavulanate Potassium	medsource pharmaceuticals	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	Unit Dose Services	2016-10-28	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	Unit Dose Services	2015-05-21	HUMAN PRESCRIPTION DRUG LABEL	3