Amoxicillin

Product NDC: 63187-343
11-digit product format: 631870343
Labeler code: 63187
Product ID: 63187-343_c0a2fcb0-d8d4-4286-a139-1d3b2bcb74b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA064013
Marketing category: ANDA
Marketing start: 1993-01-01
Substance: AMOXICILLIN
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A064013-001	AMOXICILLIN	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22
A064013-002	AMOXICILLIN	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	AB	RS	1992-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL	AB		1995-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A064013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064013-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064013-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064013-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064013-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064013-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064013-002	AB	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	250 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-343-30	Amoxicillin	30 in 1 BOTTLE	TABLET, CHEWABLE	30		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-343	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 1 package rows	20241024_52e676e4-b70e-4e73-bbe7-f54d91ca7e0a.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 · 10 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): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	26e257d5-5b98-3795-e063-6394a90a05bc	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	98e9274c-c02e-44d9-8cc5-17536ef03a77	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Proficient Rx LP	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 63187-343
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	63b395ca-f0ea-4429-b8aa-18f495596e4d	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
598025	amoxicillin 250 MG Chewable Tablet	PSN	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	5
598025	amoxicillin 250 MG Chewable Tablet	SCD	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-343-30	63187034330	30 TABLET, CHEWABLE in 1 BOTTLE (63187-343-30)	1993-01-01	0000-00-00	No	No	Current