AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 42571-162
11-digit product format: 425710162
Labeler code: 42571
Product ID: 42571-162_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: ANDA204755
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875; 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB		2016-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204755-003	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 · 41 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	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204755-003	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2016-12-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204755-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204755-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204755-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204755-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204755-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204755-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204755-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204755-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204755-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204755-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204755-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204755-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204755-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204755-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204755-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204755-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204755-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204755-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204755-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204755-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204755-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204755-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204755-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204755-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204755-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204755-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204755-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204755-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204755-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204755-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204755-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204755-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204755-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204755-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204755-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204755-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204755-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204755-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204755-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204755-003	AB	1	`cb3db0bc1861…`

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	875 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
42571-162-01	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
42571-162-01	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
42571-162-42	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
42571-162-42	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
42571-162-44	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
42571-162-44	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
42571-162-01	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
42571-162-01	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
42571-162-42	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
42571-162-42	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
42571-162-44	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
42571-162-44	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
42571-162-01	AMOXICILLIN AND CLAVULANATE POTASSIUM	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
42571-162-42	AMOXICILLIN AND CLAVULANATE POTASSIUM	20 in 1 BOTTLE	TABLET, FILM COATED	20	25
42571-162-43	AMOXICILLIN AND CLAVULANATE POTASSIUM	4 in 1 BLISTER PACK	TABLET, FILM COATED	4	25
42571-162-44	AMOXICILLIN AND CLAVULANATE POTASSIUM	4 in 1 CARTON	TABLET, FILM COATED	4	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-162-01	EA - Each	42571-162	4b91eaac-e2d6-4c19-953c-feebeb525718	1	2017-09-11
42571-162-42	EA - Each	42571-162	fa7d7480-6d23-4e16-aafe-d050058d98fd	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-162	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 · 15 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.	a26f2ceb-bb9b-4813-9691-634338186860	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	fbd40fcd-bf5b-e91e-e053-6394a90a609c	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	e153a542-3a3c-48ff-84cf-970832d4e847	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Northwind Health Company, LLC	1069b873-9bf9-cb22-e063-6394a90a4feb	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
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): 204755 application number: ANDA204755 ndc (product): 42571-162
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	e08c1bee-14c8-4bd1-898c-1874251dadf8	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	3f9beabd-b579-460a-8ceb-789389b109f8	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	da5bfc31-5431-49b4-b21b-619712ab43a7	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	6285c4f2-c13b-49a9-e053-2991aa0a2b03	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	eef98beb-57d9-448a-b89c-6acd6f7b443e	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Advanced Rx Pharmacy of Tennessee, LLC	d294e4a2-8ce7-418d-e053-2a95a90ab10b	2025-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	9bd9e662-0b80-45a8-906b-3dc04ee6b3ba	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	7526a33a-18d6-36ca-e053-2a91aa0ab9f9	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Medsource Pharmaceuticals	12a00e7e-80f5-7c5e-e063-6394a90a68d2	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	bf29327f-4e43-4597-83d2-f64349bf9d9a	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204755 application number: ANDA204755

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
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	9bd9e662-0b80-45a8-906b-3dc04ee6b3ba	101
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	9bd9e662-0b80-45a8-906b-3dc04ee6b3ba	101
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	9bd9e662-0b80-45a8-906b-3dc04ee6b3ba	101
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	eef98beb-57d9-448a-b89c-6acd6f7b443e	100
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	eef98beb-57d9-448a-b89c-6acd6f7b443e	100
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	eef98beb-57d9-448a-b89c-6acd6f7b443e	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
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a26f2ceb-bb9b-4813-9691-634338186860	21
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	a26f2ceb-bb9b-4813-9691-634338186860	21
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a26f2ceb-bb9b-4813-9691-634338186860	21
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	e153a542-3a3c-48ff-84cf-970832d4e847	7
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	89092bb8-6a1c-e23e-e053-2a95a90aa750	7
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	89092bb8-6a1c-e23e-e053-2a95a90aa750	7
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	e153a542-3a3c-48ff-84cf-970832d4e847	7
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	89092bb8-6a1c-e23e-e053-2a95a90aa750	7
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	e153a542-3a3c-48ff-84cf-970832d4e847	7
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	da5bfc31-5431-49b4-b21b-619712ab43a7	6
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	6285c4f2-c13b-49a9-e053-2991aa0a2b03	6
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	d294e4a2-8ce7-418d-e053-2a95a90ab10b	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	6285c4f2-c13b-49a9-e053-2991aa0a2b03	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	da5bfc31-5431-49b4-b21b-619712ab43a7	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	d294e4a2-8ce7-418d-e053-2a95a90ab10b	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	da5bfc31-5431-49b4-b21b-619712ab43a7	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	d294e4a2-8ce7-418d-e053-2a95a90ab10b	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	6285c4f2-c13b-49a9-e053-2991aa0a2b03	6
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	7526a33a-18d6-36ca-e053-2a91aa0ab9f9	5
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	7526a33a-18d6-36ca-e053-2a91aa0ab9f9	5
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	7526a33a-18d6-36ca-e053-2a91aa0ab9f9	5
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	e08c1bee-14c8-4bd1-898c-1874251dadf8	4
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	fbd40fcd-bf5b-e91e-e053-6394a90a609c	4
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	7989371d-feed-6c25-e053-2991aa0a967d	4
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e	4
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	75d87146-e38c-0428-e053-2991aa0aeff8	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	fbd40fcd-bf5b-e91e-e053-6394a90a609c	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	75d87146-e38c-0428-e053-2991aa0aeff8	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	e08c1bee-14c8-4bd1-898c-1874251dadf8	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	7989371d-feed-6c25-e053-2991aa0a967d	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	7989371d-feed-6c25-e053-2991aa0a967d	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	fbd40fcd-bf5b-e91e-e053-6394a90a609c	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	75d87146-e38c-0428-e053-2991aa0aeff8	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	e08c1bee-14c8-4bd1-898c-1874251dadf8	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e	4
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	1069b873-9bf9-cb22-e063-6394a90a4feb	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	748d92d8-e832-475a-bff8-5435a34996b3	3
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	748d92d8-e832-475a-bff8-5435a34996b3	3
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	1069b873-9bf9-cb22-e063-6394a90a4feb	3
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	748d92d8-e832-475a-bff8-5435a34996b3	3
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	1069b873-9bf9-cb22-e063-6394a90a4feb	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	12a00e7e-80f5-7c5e-e063-6394a90a68d2	1
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	bf29327f-4e43-4597-83d2-f64349bf9d9a	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	12a00e7e-80f5-7c5e-e063-6394a90a68d2	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	bf29327f-4e43-4597-83d2-f64349bf9d9a	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	12a00e7e-80f5-7c5e-e063-6394a90a68d2	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	bf29327f-4e43-4597-83d2-f64349bf9d9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-162-01	42571016201	100 TABLET, FILM COATED in 1 BOTTLE (42571-162-01)		2017-03-01	0000-00-00	No	No	Current
42571-162-42	42571016242	20 TABLET, FILM COATED in 1 BOTTLE (42571-162-42)		2017-03-01	0000-00-00	No	No	Current
42571-162-43	42571016243	4 in 1 BLISTER PACK						Historical
42571-162-44	42571016244	4 BLISTER PACK in 1 CARTON (42571-162-44) / 4 TABLET, FILM COATED in 1 BLISTER PACK (42571-162-43)	4 blister pack	2017-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	6
AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	22
AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	9
AMOXICILLIN AND CLAVULANATE POTASSIUM	Northwind Health Company, LLC	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	4
AMOXICILLIN AND CLAVULANATE POTASSIUM	Micro Labs Limited	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	26
AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	6
AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	6
AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	100
Amoxicillin and Clavulanate Potassium Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2025-02-02	HUMAN PRESCRIPTION DRUG LABEL	6
AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	101
AMOXICILLIN AND CLAVULANATE POTASSIUM - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	7
AMOXICILLIN AND CLAVULANATE POTASSIUM	Medsource Pharmaceuticals \| Micro Labs Limited	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
AMOXICILLIN AND CLAVULANATE POTASSIUM	RPK Pharmaceuticals, Inc.	2023-08-07	HUMAN PRESCRIPTION DRUG LABEL	3
AMOXICILLIN/CLAV POT 875/125mg	DIRECT RX	2023-04-20	HUMAN PRESCRIPTION DRUG LABEL	4