AMOXICILLIN

Product NDC: 63187-027
11-digit product format: 631870027
Labeler code: 63187
Product ID: 63187-027_7f4ab0f1-5f3f-422a-a945-f4f664ceb12d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA050760
Marketing category: NDA
Marketing start: 1999-04-15
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 400 mg/5mL
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	63187-027		D	Discontinued by firm		2026-10-05
excluded package	package	63187-027	63187-027-00	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	63187-027-00	`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	63187-027-00	`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
N050760-001	AMOXIL	AMOXICILLIN	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15
N050760-002	AMOXIL	AMOXICILLIN	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050760-002	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 · 86 observed 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
2026-09-14 22:38:34	2026-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	AB	RLD	1999-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050760-001	AMOXIL	200MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050760-002	AMOXIL	400MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050760-001	AMOXIL	200MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050760-002	AMOXIL	400MG/5ML	FOR SUSPENSION / ORAL		RLD	1999-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050760-001	AMOXIL	200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050760-002	AMOXIL	400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL		RLD	1999-04-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050760-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050760-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050760-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050760-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050760-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050760-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050760-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050760-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050760-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050760-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050760-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050760-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050760-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050760-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050760-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050760-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050760-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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
63187-027	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	4	Legacy NDC	20191121_5d080267-a1ad-4714-8fcd-ca291fbd1ef4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	USAntibiotics, LLC	06e5c07d-d95c-4955-8d35-a4703ca2359e	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760
Amoxicillin	AMOXICILLIN	ASCLEMED USA INC.	08100595-e6de-4a8a-a177-a94f849bbe9f	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4528f48d-5bda-b307-e063-6294a90a294c	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050760 application number: NDA050760

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-027-00	63187002700	100 mL in 1 BOTTLE (63187-027-00)	100 ml	2018-11-01	0000-00-00	No	No	Current