Amoxicillin

Product NDC: 67046-0316
11-digit product format: 670460316
Labeler code: 67046
Product ID: 67046-0316_52bd6bff-b459-7159-e063-6294a90ae7f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA064076
Marketing category: ANDA
Marketing start: 2026-05-26
Substance: AMOXICILLIN
Active strength: 500 mg/1
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 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
A064076-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		1994-09-30
A064076-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		1994-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064076-001	AB
A064076-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`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	A064076-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064076-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064076-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064076-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064076-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064076-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064076-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064076-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064076-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064076-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064076-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064076-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064076-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064076-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064076-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064076-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064076-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064076-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	500 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
308191	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
52bd03c6-528a-c443-e063-6394a90aad39	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
67046-0316-3	Amoxicillin	30 in 1 BLISTER PACK	CAPSULE	30		1

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	102c62ca-da20-4866-84a8-e3513824af4a	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	4ecefd37-9847-1d93-e063-6394a90a19f0	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Coupler LLC	52bd03c6-528a-c443-e063-6394a90aad39	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076 ndc (product): 67046-0316
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	be7d8459-b8e6-499a-ab87-99bd17492525	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	QPharma Inc	ddd1307d-3216-0e59-e053-2995a90ad19d	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Coupler LLC	50fff2b8-8bf1-ff46-e063-6394a90a9213	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	82c0c5d1-df2d-4352-bd12-99f955af569e	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	bb95fd06-f200-4de3-bfae-84d642d8e0f3	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76ba0f8d-4d1c-a5ff-e053-2a91aa0a7555	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6e9bf369-2f96-c7ae-e053-2a91aa0a715f	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	7b182161-128e-430c-98b2-592c242ba711	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	260a3a79-9dd6-4c4b-82ec-f8050346e886	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	aee851cf-428e-4d29-a281-078fe00c56b0	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	9925773d-8ea1-4193-91e3-52cc1ce5ca67	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	c5d39ce2-8ae4-4bba-893f-a713afba1893	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	f27237d7-123a-44ba-97df-b2446a94e3e5	2021-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Proficient Rx LP	9528a356-4101-4be2-a7e2-b0659e169e1a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076

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
308191	amoxicillin 500 MG Oral Capsule	PSN	52bd03c6-528a-c443-e063-6394a90aad39	1
308191	amoxicillin 500 MG Oral Capsule	SCD	52bd03c6-528a-c443-e063-6394a90aad39	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	52bd03c6-528a-c443-e063-6394a90aad39	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0316-3	67046031603	30 CAPSULE in 1 BLISTER PACK (67046-0316-3)	30 capsule	2026-05-26	No	No	Current