Amoxicillin

Product NDC: 57237-031
11-digit product format: 572370031
Labeler code: 57237
Product ID: 57237-031_4e6f21c7-0e2a-4361-9549-ab42efd08d5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`84e616aacf4f…`
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…`

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	A065271-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065271-002	AB	1	`84e616aacf4f…`
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…`

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: 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
bbe590a0-4196-4885-b679-cc1833af567f	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
57237-031-01	Amoxicillin	100 in 1 BOTTLE	CAPSULE	100		9
57237-031-05	Amoxicillin	500 in 1 BOTTLE	CAPSULE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-031-01	EA - Each	57237-031	e38ef169-4fdc-4983-82aa-0428963592f3	1	2014-04-03
57237-031-05	EA - Each	57237-031	f14a3f48-6f59-4a7f-8cb1-b093b88c6f75	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	11
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [PROFICIENT RX LP]	3
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-031	AMOXICILLIN CAPSULE [RISING PHARMA HOLDINGS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240306_bbe590a0-4196-4885-b679-cc1833af567f.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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	071086f5-e4ed-b1d9-e063-6294a90ad304	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bbaeb509-ad04-4668-a1db-4358038893f2	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	d0938df9-9065-47eb-9eae-0722ed1411a1	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	987786a1-d748-4b42-abb5-62a2f38ef195	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	1c755ad7-f0a8-4a63-a686-413bae57f8d0	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	5d0132d0-1d5a-46d0-bc62-76d62a7bd19d	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	c0343d5e-96b2-46fa-bf54-e2ffa0c90b41	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	95eaa9ac-c64a-4f1d-b5a3-66489d5b1edb	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceutials,Inc.	1f818d89-be59-b43d-e063-6394a90a12c3	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	d37f2e3c-01f0-4a81-a46f-1615b82e2499	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	e58a65d7-d813-446d-b70b-7465809a5d2c	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	641ec2a8-368a-4c5c-8c11-37366a06ce93	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	9d56f34f-c025-4e97-8f5e-4d93f1ab0055	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4b15c5b4-460c-449f-9e48-99870b382826	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	American Health Packaging	ecb439f7-434a-4e4c-b899-943d83346f09	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4f1c940c-9f17-4289-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Redpharm Drug	fc61c9f5-b0f8-3ff8-e053-6394a90adeb7	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6d7143e3-6a82-3613-e053-2a91aa0a8f65	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Northwind Pharmaceuticals, LLC	26114563-c719-46da-b976-3e4271533f28	2025-01-02	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	5edc5d32-43d5-4418-9832-40363a919edc	17
308191	amoxicillin 500 MG Oral Capsule	PSN	5edc5d32-43d5-4418-9832-40363a919edc	17
308182	amoxicillin 250 MG Oral Capsule	SCD	5edc5d32-43d5-4418-9832-40363a919edc	17
308191	amoxicillin 500 MG Oral Capsule	SCD	5edc5d32-43d5-4418-9832-40363a919edc	17
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	5edc5d32-43d5-4418-9832-40363a919edc	17
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	5edc5d32-43d5-4418-9832-40363a919edc	17
308191	amoxicillin 500 MG Oral Capsule	PSN	e13cafe2-f226-4021-81d8-7bd1f98b5582	12
308191	amoxicillin 500 MG Oral Capsule	SCD	e13cafe2-f226-4021-81d8-7bd1f98b5582	12
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	e13cafe2-f226-4021-81d8-7bd1f98b5582	12
308182	amoxicillin 250 MG Oral Capsule	PSN	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308191	amoxicillin 500 MG Oral Capsule	PSN	afb4149a-0714-4a85-b9e8-2379a8e6a302	11
308191	amoxicillin 500 MG Oral Capsule	PSN	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308182	amoxicillin 250 MG Oral Capsule	SCD	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308191	amoxicillin 500 MG Oral Capsule	SCD	afb4149a-0714-4a85-b9e8-2379a8e6a302	11
308191	amoxicillin 500 MG Oral Capsule	SCD	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	23979212-e989-4a8e-8dc8-46c5b4ecd590	11
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	afb4149a-0714-4a85-b9e8-2379a8e6a302	11
308191	amoxicillin 500 MG Oral Capsule	PSN	c9300368-330a-41bd-97ca-c90ea9159c6d	10
308191	amoxicillin 500 MG Oral Capsule	SCD	c9300368-330a-41bd-97ca-c90ea9159c6d	10
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	c9300368-330a-41bd-97ca-c90ea9159c6d	10
308182	amoxicillin 250 MG Oral Capsule	PSN	bbe590a0-4196-4885-b679-cc1833af567f	9
308191	amoxicillin 500 MG Oral Capsule	PSN	ef03286b-4ba7-4952-9ab1-90cacf300504	9
308191	amoxicillin 500 MG Oral Capsule	PSN	bbe590a0-4196-4885-b679-cc1833af567f	9
308182	amoxicillin 250 MG Oral Capsule	SCD	bbe590a0-4196-4885-b679-cc1833af567f	9
308191	amoxicillin 500 MG Oral Capsule	SCD	ef03286b-4ba7-4952-9ab1-90cacf300504	9
308191	amoxicillin 500 MG Oral Capsule	SCD	bbe590a0-4196-4885-b679-cc1833af567f	9
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	bbe590a0-4196-4885-b679-cc1833af567f	9
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	ef03286b-4ba7-4952-9ab1-90cacf300504	9
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	bbe590a0-4196-4885-b679-cc1833af567f	9
308191	amoxicillin 500 MG Oral Capsule	PSN	3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6	8
308191	amoxicillin 500 MG Oral Capsule	SCD	3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6	8
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6	8
308191	amoxicillin 500 MG Oral Capsule	PSN	7ee6b6b6-ae5b-2e39-e053-2991aa0a2377	7
308191	amoxicillin 500 MG Oral Capsule	SCD	7ee6b6b6-ae5b-2e39-e053-2991aa0a2377	7
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	7ee6b6b6-ae5b-2e39-e053-2991aa0a2377	7
308191	amoxicillin 500 MG Oral Capsule	PSN	8995ac88-a094-2d16-e053-2a95a90a9a26	6
308191	amoxicillin 500 MG Oral Capsule	PSN	05e88717-2ce3-4b1a-88af-c3f61a2d8cd5	6
308191	amoxicillin 500 MG Oral Capsule	SCD	8995ac88-a094-2d16-e053-2a95a90a9a26	6
308191	amoxicillin 500 MG Oral Capsule	SCD	05e88717-2ce3-4b1a-88af-c3f61a2d8cd5	6
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	8995ac88-a094-2d16-e053-2a95a90a9a26	6
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	05e88717-2ce3-4b1a-88af-c3f61a2d8cd5	6
308191	amoxicillin 500 MG Oral Capsule	PSN	800f5fac-f2af-358f-e053-2a91aa0ad6a6	5
308191	amoxicillin 500 MG Oral Capsule	PSN	4eb83e73-9dba-07ae-e054-00144ff8d46c	5
308191	amoxicillin 500 MG Oral Capsule	SCD	800f5fac-f2af-358f-e053-2a91aa0ad6a6	5
308191	amoxicillin 500 MG Oral Capsule	SCD	4eb83e73-9dba-07ae-e054-00144ff8d46c	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	800f5fac-f2af-358f-e053-2a91aa0ad6a6	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	4eb83e73-9dba-07ae-e054-00144ff8d46c	5
308191	amoxicillin 500 MG Oral Capsule	PSN	f049551b-4708-eb13-e053-2a95a90afd1f	3
308191	amoxicillin 500 MG Oral Capsule	SCD	f049551b-4708-eb13-e053-2a95a90afd1f	3
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	f049551b-4708-eb13-e053-2a95a90afd1f	3
308191	amoxicillin 500 MG Oral Capsule	PSN	5020950a-b248-a463-e063-6294a90ae57f	1
308191	amoxicillin 500 MG Oral Capsule	SCD	5020950a-b248-a463-e063-6294a90ae57f	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	5020950a-b248-a463-e063-6294a90ae57f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-031-01	57237003101	100 CAPSULE in 1 BOTTLE (57237-031-01)	100 capsule	2005-11-09	0000-00-00	No	No	Current
57237-031-05	57237003105	500 CAPSULE in 1 BOTTLE (57237-031-05)	500 capsule	2005-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	REMEDYREPACK INC.	2026-08-06	HUMAN PRESCRIPTION DRUG LABEL	12
Amoxicillin - Proficient Rx LP	Proficient Rx LP	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	10
Amoxicillin	Coupler LLC \| Aurobindo Pharma Limited	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceuticalls,Inc.	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin 500 mg Pack	Health Department, Oklahoma State	2025-12-13	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	A-S Medication Solutions	2024-11-04	Human Prescription Drug Label	17
Amoxicillin	A-S Medication Solutions	2024-11-04	Human Prescription Drug Label	12
Amoxicillin	A-S Medication Solutions	2024-11-04	Human Prescription Drug Label	8
Amoxicillin	A-S Medication Solutions	2024-11-04	Human Prescription Drug Label	6
Amoxicillin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	7
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	6
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	23
Amoxicillin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-02-27	Human Prescription Drug Label	9
Amoxicillin	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	11
Amoxicillin	Unit Dose Services	2022-05-23	Human Prescription Drug Label	10
Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC \| Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2021-10-15	Human Prescription Drug Label	4
Amoxicillin	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	NuCare Pharmaceuticals,Inc.	2017-09-06	HUMAN PRESCRIPTION DRUG LABEL	1