AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 42571-160
11-digit product format: 425710160
Labeler code: 42571
Product ID: 42571-160_3a71d6d7-6111-a0f8-e063-6394a90aa0e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA205707
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250; 125 mg/1; mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2016-12-30
A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2016-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205707-001	AB
A205707-002	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	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205707-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205707-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`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	A205707-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205707-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205707-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205707-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205707-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205707-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205707-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205707-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205707-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205707-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205707-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205707-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205707-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205707-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205707-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205707-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205707-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205707-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205707-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205707-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205707-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205707-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205707-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205707-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205707-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205707-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205707-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205707-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205707-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205707-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205707-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205707-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205707-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205707-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205707-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205707-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205707-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205707-002	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	250 mg/1
CLAVULANATE POTASSIUM	125 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562251	Internal RxNorm lookup
562508	Internal RxNorm lookup
617296	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
0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
42571-160-01	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-01	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-11	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-11	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-30	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-30	2020-07-29	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-01	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-01	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-11	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-11	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-30	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-160-30	2020-07-22	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-160-01	AMOXICILLIN AND CLAVULANATE POTASSIUM	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
42571-160-11	AMOXICILLIN AND CLAVULANATE POTASSIUM	10 in 1 CARTON	TABLET, FILM COATED	10	25
42571-160-30	AMOXICILLIN AND CLAVULANATE POTASSIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
42571-160-32	AMOXICILLIN AND CLAVULANATE POTASSIUM	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-160-30	EA - Each	42571-160	96e920c2-b36e-4fa1-83d5-7ea0fd67b110	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-160	AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED [MICRO LABS LIMITED]	24	Current NDC, Legacy NDC, 4 package rows	20240927_0c2d1fbc-f80c-4737-a15e-9cfa6bf99769.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 · 14 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	REMEDYREPACK INC.	6e1c6209-660f-4043-b6a6-eac5f7665ef9	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Micro Labs Limited	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707 ndc (product): 42571-160
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Coupler LLC	513b6211-c73b-7e66-e063-6394a90a2aa1	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	56fb634c-3725-4d0a-8f20-584652a1d99f	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	aa15e6f6-1eb1-41ab-b3cb-bf24d09fc882	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	b5e66987-09e3-45b2-88ba-59c8647d724e	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
Amoxicillin/Clav Pot	AMOXICILLIN/CLAV POT	Direct_Rx	3b4f868d-6a3e-8276-e063-6294a90a6457	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	d7c0a364-d5d1-432d-823b-844a2d0b6780	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	b9bcd4a4-d4ae-4460-9eff-e80439fafd6f	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	64a27ad7-4d32-69c8-e053-2a91aa0aa967	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6542fa18-6219-602f-e053-2991aa0a54d0	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6635fda2-15c3-2ff5-e053-2991aa0a5abb	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Medsource Pharmaceuticals	1275ad58-c53f-20d0-e063-6394a90a4a43	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	f17fddd3-aecc-456c-9b2b-f33b7fdb353e	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205707 application number: ANDA205707

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
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	aa15e6f6-1eb1-41ab-b3cb-bf24d09fc882	100
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	b9bcd4a4-d4ae-4460-9eff-e80439fafd6f	100
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	aa15e6f6-1eb1-41ab-b3cb-bf24d09fc882	100
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	b9bcd4a4-d4ae-4460-9eff-e80439fafd6f	100
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	aa15e6f6-1eb1-41ab-b3cb-bf24d09fc882	100
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	b9bcd4a4-d4ae-4460-9eff-e80439fafd6f	100
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	0c2d1fbc-f80c-4737-a15e-9cfa6bf99769	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-160-01	42571016001	100 TABLET, FILM COATED in 1 BOTTLE (42571-160-01)		2017-03-01	0000-00-00	No	No	Current
42571-160-11	42571016011	10 BLISTER PACK in 1 CARTON (42571-160-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-160-32)	10 blister pack	2017-03-01	0000-00-00	No	No	Current
42571-160-30	42571016030	30 TABLET, FILM COATED in 1 BOTTLE (42571-160-30)		2017-03-01	0000-00-00	No	No	Current
42571-160-32	42571016032	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	Micro Labs Limited	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	26
AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	100
AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	100