AMOXICILLIN

Product NDC: 63187-013
11-digit product format: 631870013
Labeler code: 63187
Product ID: 63187-013_7f4ab0f1-5f3f-422a-a945-f4f664ceb12d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA050754
Marketing category: NDA
Marketing start: 1978-07-10
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 875 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	63187-013		D	Discontinued by firm		2026-10-05
excluded package	package	63187-013	63187-013-20	D	Discontinued by firm		2026-10-05

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 · 4 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	63187-013-20	`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	63187-013-20	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050754-001	AMOXIL	AMOXICILLIN	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-07-10
N050754-002	AMOXIL	AMOXICILLIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-07-10

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050754-001	AMOXIL	875MG	TABLET / ORAL	RLD	1998-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050754-002	AMOXIL	500MG	TABLET / ORAL	RLD	1998-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050754-001	AMOXIL	875MG	TABLET / ORAL	RLD	1998-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050754-002	AMOXIL	500MG	TABLET / ORAL	RLD	1998-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050754-001	AMOXIL	875MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1998-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050754-002	AMOXIL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1998-07-10	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-013-20	EA - Each	63187-013	c07989db-c2bc-4a29-9dce-a8fcf7474648	1	2023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SODIUM	INACTIVE INGREDIENT	9NEZ333N27	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-013	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	4	Legacy NDC	20191121_5d080267-a1ad-4714-8fcd-ca291fbd1ef4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-013-20	63187001320	20 TABLET, FILM COATED in 1 BOTTLE (63187-013-20)	2018-12-01	0000-00-00	No	No	Current