Amoxicillin

Product NDC: 16714-299
11-digit product format: 167140299
Labeler code: 16714
Product ID: 16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA065271
Marketing category: ANDA
Marketing start: 2005-11-09
Substance: AMOXICILLIN
Active strength: 500 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 42.

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
A065271-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		2005-11-09
A065271-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065271-001	AB
A065271-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`

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	A065271-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065271-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065271-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065271-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065271-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065271-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065271-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065271-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065271-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065271-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065271-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065271-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065271-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065271-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065271-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065271-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065271-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065271-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065271-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065271-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065271-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065271-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065271-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065271-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308182	Internal RxNorm lookup
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
843f6053-63d9-47d2-81f1-b6aa78a7c20c	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	SPL version
16714-299-01	Amoxicillin	30 in 1 BOTTLE	CAPSULE	30	13
16714-299-02	Amoxicillin	50 in 1 BOTTLE	CAPSULE	50	13
16714-299-03	Amoxicillin	100 in 1 BOTTLE	CAPSULE	100	13
16714-299-04	Amoxicillin	500 in 1 BOTTLE	CAPSULE	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-299-02	EA - Each	16714-299	46b3d736-2fe1-4c73-bcd9-94a375d5edcf	1	2012-07-24
16714-299-03	EA - Each	16714-299	4d1e8a6a-b477-4b1d-a94a-0572dff91356	1	2012-07-24
16714-299-04	EA - Each	16714-299	05ddd977-2656-4ba8-8033-506812927472	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-299	AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]	13	Current NDC, Legacy NDC, 4 package rows	20240305_843f6053-63d9-47d2-81f1-b6aa78a7c20c.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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Redpharm Drug	57f5652d-ee50-eb7e-e063-6394a90a7b66	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Redpharm Drug	57e56202-950b-10f6-e063-6394a90a4912	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	1d0d8bc4-137e-ef10-e063-6294a90acf62	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	53548597-347b-42a9-916c-e88cd27b8dcd	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ef03286b-4ba7-4952-9ab1-90cacf300504	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5155ca5d-fe58-42b4-e063-6394a90ab135	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin 500 mg	AMOXICILLIN	Health Department, Oklahoma State	f049551b-4708-eb13-e053-2a95a90afd1f	2025-12-13		Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	32b224c2-1354-4b58-b082-b93330e6962b	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271

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	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308191	amoxicillin 500 MG Oral Capsule	PSN	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308182	amoxicillin 250 MG Oral Capsule	SCD	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308191	amoxicillin 500 MG Oral Capsule	SCD	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	843f6053-63d9-47d2-81f1-b6aa78a7c20c	13
308191	amoxicillin 500 MG Oral Capsule	PSN	4d0f063a-d896-4757-8f22-9614e2ad71d4	12
308191	amoxicillin 500 MG Oral Capsule	SCD	4d0f063a-d896-4757-8f22-9614e2ad71d4	12
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	4d0f063a-d896-4757-8f22-9614e2ad71d4	12
308191	amoxicillin 500 MG Oral Capsule	PSN	322feb95-8bd4-440a-bda2-29ee19b11234	8
308191	amoxicillin 500 MG Oral Capsule	SCD	322feb95-8bd4-440a-bda2-29ee19b11234	8
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	322feb95-8bd4-440a-bda2-29ee19b11234	8
308191	amoxicillin 500 MG Oral Capsule	PSN	071086f5-e4ed-b1d9-e063-6294a90ad304	7
308191	amoxicillin 500 MG Oral Capsule	PSN	26202694-cf20-4b08-90cc-70a3d30cbb0f	7
308191	amoxicillin 500 MG Oral Capsule	SCD	26202694-cf20-4b08-90cc-70a3d30cbb0f	7
308191	amoxicillin 500 MG Oral Capsule	SCD	071086f5-e4ed-b1d9-e063-6294a90ad304	7
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	071086f5-e4ed-b1d9-e063-6294a90ad304	7
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	26202694-cf20-4b08-90cc-70a3d30cbb0f	7
308191	amoxicillin 500 MG Oral Capsule	PSN	1f818d89-be59-b43d-e063-6394a90a12c3	4
308191	amoxicillin 500 MG Oral Capsule	SCD	1f818d89-be59-b43d-e063-6394a90a12c3	4
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	1f818d89-be59-b43d-e063-6394a90a12c3	4
308191	amoxicillin 500 MG Oral Capsule	PSN	66404ced-5ef4-4a31-9276-8c6f86add61c	3
308191	amoxicillin 500 MG Oral Capsule	PSN	73219f24-6eac-4472-b2a7-cad36936c185	3
308191	amoxicillin 500 MG Oral Capsule	SCD	66404ced-5ef4-4a31-9276-8c6f86add61c	3
308191	amoxicillin 500 MG Oral Capsule	SCD	73219f24-6eac-4472-b2a7-cad36936c185	3
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	66404ced-5ef4-4a31-9276-8c6f86add61c	3
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	73219f24-6eac-4472-b2a7-cad36936c185	3
308191	amoxicillin 500 MG Oral Capsule	PSN	f4e99b4f-2cf4-ba35-e053-2a95a90ada5f	2
308191	amoxicillin 500 MG Oral Capsule	PSN	32b224c2-1354-4b58-b082-b93330e6962b	2
308191	amoxicillin 500 MG Oral Capsule	SCD	f4e99b4f-2cf4-ba35-e053-2a95a90ada5f	2
308191	amoxicillin 500 MG Oral Capsule	SCD	32b224c2-1354-4b58-b082-b93330e6962b	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	f4e99b4f-2cf4-ba35-e053-2a95a90ada5f	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	32b224c2-1354-4b58-b082-b93330e6962b	2
308191	amoxicillin 500 MG Oral Capsule	PSN	116f655e-e32f-5030-e063-6394a90a64e5	1
308191	amoxicillin 500 MG Oral Capsule	PSN	fe9e12de-9be9-4211-9a58-c7ecd9e838d5	1
308191	amoxicillin 500 MG Oral Capsule	PSN	5b42ae30-96b2-4ceb-8b7c-468a6816305b	1
308191	amoxicillin 500 MG Oral Capsule	SCD	116f655e-e32f-5030-e063-6394a90a64e5	1
308191	amoxicillin 500 MG Oral Capsule	SCD	5b42ae30-96b2-4ceb-8b7c-468a6816305b	1
308191	amoxicillin 500 MG Oral Capsule	SCD	fe9e12de-9be9-4211-9a58-c7ecd9e838d5	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	fe9e12de-9be9-4211-9a58-c7ecd9e838d5	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	5b42ae30-96b2-4ceb-8b7c-468a6816305b	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	116f655e-e32f-5030-e063-6394a90a64e5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-299-01	16714029901	30 CAPSULE in 1 BOTTLE (16714-299-01)	30 capsule	2005-11-09	0000-00-00	No	No	Current
16714-299-02	16714029902	50 CAPSULE in 1 BOTTLE (16714-299-02)	50 capsule	2005-11-09	0000-00-00	No	No	Current
16714-299-03	16714029903	100 CAPSULE in 1 BOTTLE (16714-299-03)	100 capsule	2005-11-09	0000-00-00	No	No	Current
16714-299-04	16714029904	500 CAPSULE in 1 BOTTLE (16714-299-04)	500 capsule	2005-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	Redpharm Drug	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	NuCare Pharmaceuticals,Inc.	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	7
Amoxicillin	NuCare Pharmaceutials,Inc. \| NuCare Pharmaceuticals, Inc.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	A-S Medication Solutions	2024-04-15	Human Prescription Drug Label	8
Amoxicillin	A-S Medication Solutions	2024-04-11	Human Prescription Drug Label	12
Amoxicillin	A-S Medication Solutions	2024-04-11	Human Prescription Drug Label	7
Amoxicillin	A-S Medication Solutions	2024-04-11	Human Prescription Drug Label	3
Amoxicillin	NorthStar Rx LLC \| Aurobindo Pharma Limited	2024-03-02	Human Prescription Drug Label	13
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-02-15	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	Proficient Rx LP	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-11-02	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	A-S Medication Solutions	2018-03-29	Human Prescription Drug Label	5
Amoxicillin	Central Texas Community Health Centers	2017-08-23	Human Prescription Drug Label	1