Amoxicillin and Clavulanate Potassium

Product NDC: 69043-027
11-digit product format: 690430027
Labeler code: 69043
Product ID: 69043-027_90f51e45-8901-49d3-a7d1-554e24abe594
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Cronus Pharma LLC
Application: ANDA209371
Marketing category: ANDA
Marketing start: 2019-04-19
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250 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: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69043-027		D	Discontinued by firm		2026-08-03
excluded package	package	69043-027	69043-027-75	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69043-027-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69043-027-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69043-027-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69043-027-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69043-027-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69043-027-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69043-027-75	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69043-027-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69043-027-75	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69043-027-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69043-027-75	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69043-027-75	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2019-04-19
A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2019-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209371-001	AB
A209371-002	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	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209371-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	125MG/5ML;EQ 31.25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209371-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG/5ML;EQ 62.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-04-19	`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	A209371-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209371-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209371-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209371-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209371-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209371-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209371-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209371-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209371-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209371-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209371-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209371-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209371-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209371-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209371-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209371-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209371-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209371-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209371-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209371-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209371-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209371-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209371-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209371-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209371-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209371-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209371-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209371-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209371-002	AB	1	`782e0a99824c…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69043-027-18	Carprofen	180 in 1 BOTTLE	TABLET, CHEWABLE	180		5
69043-027-60	Carprofen	60 in 1 BOTTLE	TABLET, CHEWABLE	60		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69043-027	CARPROFEN TABLET, CHEWABLE [CRONUS PHARMA LLC]	4	Legacy NDC, 2 package rows	20240725_3c088145-0f3e-4fb6-9b46-d53344de1b82.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 · 1 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	Aurobindo Pharma Limited	3ae0c95f-7ffa-4317-9fea-4d07b86bee72	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209371 application number: ANDA209371

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
860125	carprofen 100 MG Chewable Tablet	PSN	3c088145-0f3e-4fb6-9b46-d53344de1b82	5
847142	carprofen 25 MG Chewable Tablet	PSN	3c088145-0f3e-4fb6-9b46-d53344de1b82	5
847147	carprofen 75 MG Chewable Tablet	PSN	3c088145-0f3e-4fb6-9b46-d53344de1b82	5
860125	carprofen 100 MG Chewable Tablet	SCD	3c088145-0f3e-4fb6-9b46-d53344de1b82	5
847142	carprofen 25 MG Chewable Tablet	SCD	3c088145-0f3e-4fb6-9b46-d53344de1b82	5
847147	carprofen 75 MG Chewable Tablet	SCD	3c088145-0f3e-4fb6-9b46-d53344de1b82	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69043-027-18	69043002718	180 in 1 BOTTLE	Historical
69043-027-60	69043002760	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carprofen Chewable Tablets (carprofen) Non-steroidal anti-inflammatory drug For oral use in dogs only	Cronus Pharma LLC	2025-08-26	Prescription Animal Drug Label	5
Amoxicillin and Clavulanate Potassium	Cronus Pharma LLC \| Aurobindo Pharma Limited	2020-12-23	Human Prescription Drug Label	2