Amoxicillin

Product NDC: 67296-0002
Requested package NDC: 67296-0002-1
11-digit product format: 672960002
Labeler code: 67296
Product ID: 67296-0002_3d018e0f-e47d-7472-e063-6294a90a2fe2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA061926
Marketing category: ANDA
Marketing start: 1990-09-30
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
A061926-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A061926-003	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061926-001	AB
A061926-003	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 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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061926-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061926-003	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A061926-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061926-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061926-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061926-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061926-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061926-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061926-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061926-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061926-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061926-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061926-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061926-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061926-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061926-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061926-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061926-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061926-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061926-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061926-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061926-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061926-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061926-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061926-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061926-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061926-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061926-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061926-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061926-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061926-003	AB	1	`782e0a99824c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Chartwell Governmental & Specialty RX, LLC	809393b7-6271-4715-ae84-13fd8f901772	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	QPharma, Inc	60c788d1-6c91-4456-848a-893e649e90be	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	Redpharm Drug	3d0025b4-b7bb-69db-e063-6294a90a0e70	2025-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926 ndc (package): 67296-0002-1 ndc (product): 67296-0002 ndc11 (package): 67296000201
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	80a04b8a-110e-0aea-e053-2a91aa0ad057	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3ba9cf-9a28-3965-e053-2a95a90a38ce	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	be1d1a44-7ef3-445d-9970-494921de4c9d	2023-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061926 application number: ANDA061926

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
308182	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
3d0025b4-b7bb-69db-e063-6294a90a0e70	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
67296-0002-1	Amoxicillin	20 in 1 BOTTLE	CAPSULE	20		1
67296-0002-2	Amoxicillin	30 in 1 BOTTLE	CAPSULE	30		1

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
308182	amoxicillin 250 MG Oral Capsule	PSN	3d0025b4-b7bb-69db-e063-6294a90a0e70	1
308182	amoxicillin 250 MG Oral Capsule	SCD	3d0025b4-b7bb-69db-e063-6294a90a0e70	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	3d0025b4-b7bb-69db-e063-6294a90a0e70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-0002-1	67296000201	20 CAPSULE in 1 BOTTLE (67296-0002-1)	20 capsule	1990-09-30	No	No	Current