AMOXICILLIN

Product NDC: 62135-089
11-digit product format: 621350089
Labeler code: 62135
Product ID: 62135-089_5c503506-e9d5-5e8e-e063-6294a90abdc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMOXICILLIN
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA061931
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: AMOXICILLIN
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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 · 129 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	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A061931-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061931-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: AMOXICILLIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239191	Internal RxNorm lookup
308177	Internal RxNorm lookup
308182	Internal RxNorm lookup
308189	Internal RxNorm lookup
308191	Internal RxNorm lookup
308192	Internal RxNorm lookup
308194	Internal RxNorm lookup
313797	Internal RxNorm lookup
313850	Internal RxNorm lookup
598025	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
b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	Available on FDA.report

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	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931 ndc (product): 62135-089
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	Sample	Exclude flag	Status
62135-089-01	62135008901	100 mL in 1 BOTTLE (62135-089-01)	100 ml	2026-07-16	No	No	Current
62135-089-51	62135008951	150 mL in 1 BOTTLE (62135-089-51)	150 ml	2026-07-16	No	No	Current
62135-089-80	62135008980	80 mL in 1 BOTTLE (62135-089-80)	80 ml	2026-07-16	No	No	Current