AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 70518-2263
Requested package NDC: 70518-2263-1
11-digit product format: 705182263
Labeler code: 70518
Product ID: 70518-2263_4dda203b-5045-e608-e063-6294a90aa2b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204755
Marketing category: ANDA
Marketing start: 2019-08-12
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2263	70518-2263-1	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562508	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
a26f2ceb-bb9b-4813-9691-634338186860	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	SPL version
70518-2263-0	AMOXICILLIN AND CLAVULANATE POTASSIUM	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	21
70518-2263-1	AMOXICILLIN AND CLAVULANATE POTASSIUM	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	21
70518-2263-2	AMOXICILLIN AND CLAVULANATE POTASSIUM	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	21
70518-2263-3	AMOXICILLIN AND CLAVULANATE POTASSIUM	100 in 1 BOX	TABLET, FILM COATED	100	21
70518-2263-4	AMOXICILLIN AND CLAVULANATE POTASSIUM	1 in 1 POUCH	TABLET, FILM COATED	1	21
70518-2263-5	AMOXICILLIN AND CLAVULANATE POTASSIUM	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	21
70518-2263-6	AMOXICILLIN AND CLAVULANATE POTASSIUM	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	21
70518-2263-7	AMOXICILLIN AND CLAVULANATE POTASSIUM	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	21
70518-2263-8	AMOXICILLIN AND CLAVULANATE POTASSIUM	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	21
70518-2263-9	AMOXICILLIN AND CLAVULANATE POTASSIUM	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2263-0	EA - Each	70518-2263	380e087f-e3ce-4e4a-acc8-27379f05a7ec	1	2025-12-16
70518-2263-3	EA - Each	70518-2263	a634810d-7443-4985-9fe7-aa56ea80e910	1	2023-01-09
70518-2263-4	EA - Each	70518-2263	5022a308-5d88-409d-b8c8-5d463a1fce8d	1	2023-01-09
70518-2263-5	EA - Each	70518-2263	0fd3f94f-3300-4451-ab13-1af4f946efb8	1	2023-01-09
70518-2263-8	EA - Each	70518-2263	66c6bb3c-040d-4284-8c8d-37ad2fa27302	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2263	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]	17	Current NDC, Legacy NDC, 10 package rows	20250210_a26f2ceb-bb9b-4813-9691-634338186860.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 ndc (package): 70518-2263-1 ndc (product): 70518-2263 ndc11 (package): 70518226301
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
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	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	3f9beabd-b579-460a-8ceb-789389b109f8	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	3f9beabd-b579-460a-8ceb-789389b109f8	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	3f9beabd-b579-460a-8ceb-789389b109f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2263-1	70518226301	20 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-1)	2019-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	22
AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	1