Amoxicillin and Clavulanate Potassium

Product NDC: 45865-230
11-digit product format: 458650230
Labeler code: 45865
Product ID: 45865-230_1275ba9e-689e-104c-e063-6394a90a2b15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA205707
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 500; 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 45865-230
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

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate Potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	500 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
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
1275ad58-c53f-20d0-e063-6394a90a4a43	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-230-20	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-230	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Current NDC, 1 package rows	20240229_1275ad58-c53f-20d0-e063-6394a90a4a43.zip

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
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	1275ad58-c53f-20d0-e063-6394a90a4a43	1
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	1275ad58-c53f-20d0-e063-6394a90a4a43	1
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	1275ad58-c53f-20d0-e063-6394a90a4a43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
45865-230-20	45865023020	20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20)	2023-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Medsource Pharmaceuticals \| Micro Labs Limited	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	1