Amoxicillin

Product NDC: 63187-200
Requested package NDC: 63187-200-15
11-digit product format: 631870200
Labeler code: 63187
Product ID: 63187-200_21a6e3d2-041b-489e-9c24-8482e77ac51a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA061931
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 125 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-200	63187-200-15	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-200	63187-200-15	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-200	63187-200-15	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A061931-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982
A061931-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982
A061931-003	AMOXICILLIN PEDIATRIC	AMOXICILLIN	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061931-002	AB
A061931-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A061931-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061931-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061931-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061931-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061931-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061931-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061931-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061931-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061931-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061931-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061931-003	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-200-15	ML - Milliliter	63187-200	a857054b-ce0f-4007-9f11-9211f327bf03	1	2017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-200	AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	5	Legacy NDC	20210121_28589371-5f00-417c-af89-22c4b17ee4db.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	cf707c13-3b40-079c-e053-2995a90a2176	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5780c9e4-5e22-270c-e053-2a91aa0a36ba	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	bfd67724-fb22-4eac-8ebd-555614c16329	2023-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Proficient Rx LP	de792ac6-4b3d-4d34-8e50-030b5bd830d7	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931

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
63187-200-15	63187020015	150 mL in 1 BOTTLE (63187-200-15)	150 ml	2017-09-01	0000-00-00	No	No	Current