Amoxicillin and Clavulanate Potassium

Product NDC: 16714-014
11-digit product format: 167140014
Labeler code: 16714
Product ID: 16714-014_3327c23e-bb50-425b-989d-eea2568c99f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northstar RxLLC
Application: ANDA065063
Marketing category: ANDA
Marketing start: 2020-05-01
Marketing end: 2026-06-30
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
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16714-014		D	Discontinued by firm	2026-08-03
excluded package	package	16714-014	16714-014-01	D	Discontinued by firm	2026-08-03
excluded package	package	16714-014	16714-014-02	D	Discontinued by firm	2026-08-03

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
A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065063-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065063-001	AB	1	`a50c72e98297…`

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 · 11 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.	c88b2b50-c664-43b3-9c37-f134a329dc21	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	377abca8-7076-9ad0-e063-6294a90aa5dc	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	348f7f77-ba7e-5dd9-e063-6294a90a0991	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	7cba82f0-9886-46e9-8dbd-43a448aade29	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	31d00820-1c20-d52b-e063-6394a90ac312	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f9b4d263-bc5b-6065-e053-6394a90a5e35	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	a94cfba3-27ed-46a3-81ef-e9b80187c207	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	917a76e9-eb2b-4d49-9418-ff919a73cfad	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	a0d22635-0e11-448d-b151-6f6168c65723	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	5b68b2bf-b581-4372-87be-a6394ee56961	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	f636413f-82e5-446f-94cc-b4841bdedb33	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063

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	Strength	SPL version
16714-014-01	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20		18
16714-014-02	Amoxicillin and Clavulanate Potassium	100 in 1 BOTTLE	TABLET, FILM COATED	100		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-014-01	EA - Each	16714-014	d7e3c011-de11-4207-b33b-349ad14da025	1	2020-07-13
16714-014-02	EA - Each	16714-014	832bdac6-2637-462a-b2b4-07be6c47e3fd	1	2023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-014	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]	17	Current NDC, Legacy NDC, 2 package rows	20240511_d6bff811-a6ea-4e4e-a4eb-b34b966cdb40.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
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	d6bff811-a6ea-4e4e-a4eb-b34b966cdb40	18
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	32906f4a-8b21-458d-b643-e6b1b0a8bb44	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	32906f4a-8b21-458d-b643-e6b1b0a8bb44	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	32906f4a-8b21-458d-b643-e6b1b0a8bb44	4
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	f9b4d263-bc5b-6065-e053-6394a90a5e35	2
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	f9b4d263-bc5b-6065-e053-6394a90a5e35	2
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a94cfba3-27ed-46a3-81ef-e9b80187c207	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	f9b4d263-bc5b-6065-e053-6394a90a5e35	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	f636413f-82e5-446f-94cc-b4841bdedb33	1
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a0d22635-0e11-448d-b151-6f6168c65723	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	f636413f-82e5-446f-94cc-b4841bdedb33	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	a0d22635-0e11-448d-b151-6f6168c65723	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	f636413f-82e5-446f-94cc-b4841bdedb33	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a0d22635-0e11-448d-b151-6f6168c65723	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-014-01	16714001401	20 TABLET, FILM COATED in 1 BOTTLE (16714-014-01)	2020-05-01	0000-00-00	No	No	Current
16714-014-02	16714001402	100 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin and Clavulanate Potassium	Northstar RxLLC	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	18
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2023-06-22	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	1