Amoxicillin

Product NDC: 57237-028
Requested package NDC: 57237-028-01
11-digit product format: 572370028
Labeler code: 57237
Product ID: 57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA065256
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 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
A065256-001	AMOXICILLIN	AMOXICILLIN	500MG	TABLET / ORAL	AB		2005-11-09
A065256-002	AMOXICILLIN	AMOXICILLIN	875MG	TABLET / 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
A065256-001	AB
A065256-002	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	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065256-001	AMOXICILLIN	500MG	TABLET / ORAL	AB	2005-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065256-002	AMOXICILLIN	875MG	TABLET / ORAL	AB	2005-11-09	`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	A065256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065256-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065256-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065256-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065256-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065256-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065256-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065256-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065256-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065256-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065256-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065256-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065256-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065256-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065256-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065256-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065256-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065256-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065256-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065256-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065256-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065256-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065256-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065256-002	AB	1	`782e0a99824c…`

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
308192	Internal RxNorm lookup
308194	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
bb7733f8-6aad-4273-84a0-ef472630203f	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-028-01	Amoxicillin	100 in 1 BOTTLE	TABLET, FILM COATED	100		10
57237-028-20	Amoxicillin	20 in 1 BOTTLE	TABLET, FILM COATED	20		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-028-01	EA - Each	57237-028	444e2698-682f-4e11-9c07-8581fb010aa1	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-028	AMOXICILLIN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240809_bb7733f8-6aad-4273-84a0-ef472630203f.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	a2c91cf0-a4e4-44c0-b712-bee63dd6c22b	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	9618d038-e880-47f6-b8d7-bbf8ab35364d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	f37eb415-77b2-41b0-8d20-64e821e4b05d	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Proficient Rx LP	313ea909-5b1b-41ff-a0db-5aadc12e2e4f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Coupler LLC	5037e2a5-52e9-caec-e063-6294a90ad837	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	American Health Packaging	d339ea0f-8797-460f-a3b7-b8455c250366	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	4b23e6f5-9287-4c01-b795-b8c538833039	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	f1eee459-9021-b26e-e053-2995a90a7291	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	QPharma, Inc.	2700df91-c5ef-4931-9ad7-a3c1c146ccac	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8e6f9df1-0754-69e4-e053-2a95a90acc49	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	3e4f0f03-438b-ddfb-e063-6294a90adb38	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	3880b9c2-62a5-0d23-e063-6394a90a1252	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	b91f40dd-40db-473d-a399-166aeb1ce7e2	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	aaf42367-153e-4525-af5f-f5f1c7d6c559	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bef50f2a-78c6-4d0c-8ad9-cfa3c801629d	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	963986fc-0e59-21b0-e053-2a95a90a9531	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	c3d3f94f-e976-4625-9667-3d716932f2fa	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	20eb4ade-f3b8-db66-e063-6294a90ae846	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	bb7733f8-6aad-4273-84a0-ef472630203f	2024-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065256 application number: ANDA065256 ndc (package): 57237-028-01 ndc (product): 57237-028 ndc11 (package): 57237002801

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
308192	amoxicillin 500 MG Oral Tablet	PSN	b91f40dd-40db-473d-a399-166aeb1ce7e2	22
308194	amoxicillin 875 MG Oral Tablet	PSN	b91f40dd-40db-473d-a399-166aeb1ce7e2	22
308192	amoxicillin 500 MG Oral Tablet	SCD	b91f40dd-40db-473d-a399-166aeb1ce7e2	22
308194	amoxicillin 875 MG Oral Tablet	SCD	b91f40dd-40db-473d-a399-166aeb1ce7e2	22
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	b91f40dd-40db-473d-a399-166aeb1ce7e2	22
308192	amoxicillin 500 MG Oral Tablet	PSN	bb7733f8-6aad-4273-84a0-ef472630203f	10
308194	amoxicillin 875 MG Oral Tablet	PSN	bb7733f8-6aad-4273-84a0-ef472630203f	10
308192	amoxicillin 500 MG Oral Tablet	SCD	bb7733f8-6aad-4273-84a0-ef472630203f	10
308194	amoxicillin 875 MG Oral Tablet	SCD	bb7733f8-6aad-4273-84a0-ef472630203f	10
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	bb7733f8-6aad-4273-84a0-ef472630203f	10
308192	amoxicillin 500 MG Oral Tablet	PSN	f37eb415-77b2-41b0-8d20-64e821e4b05d	6
308192	amoxicillin 500 MG Oral Tablet	SCD	f37eb415-77b2-41b0-8d20-64e821e4b05d	6
308192	amoxicillin 500 MG Oral Tablet	PSN	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2
308192	amoxicillin 500 MG Oral Tablet	PSN	a0b5e3ec-2673-43cf-a79d-dc4d3855262a	2
308192	amoxicillin 500 MG Oral Tablet	PSN	73a45827-092e-9a1d-e053-2a91aa0a044f	2
308192	amoxicillin 500 MG Oral Tablet	PSN	f1eee459-9021-b26e-e053-2995a90a7291	2
308194	amoxicillin 875 MG Oral Tablet	PSN	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2
308192	amoxicillin 500 MG Oral Tablet	SCD	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2
308192	amoxicillin 500 MG Oral Tablet	SCD	a0b5e3ec-2673-43cf-a79d-dc4d3855262a	2
308192	amoxicillin 500 MG Oral Tablet	SCD	73a45827-092e-9a1d-e053-2a91aa0a044f	2
308192	amoxicillin 500 MG Oral Tablet	SCD	f1eee459-9021-b26e-e053-2995a90a7291	2
308194	amoxicillin 875 MG Oral Tablet	SCD	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2
308192	amoxicillin 500 MG Oral Tablet	PSN	20eb4ade-f3b8-db66-e063-6294a90ae846	1
308192	amoxicillin 500 MG Oral Tablet	SCD	20eb4ade-f3b8-db66-e063-6294a90ae846	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-028-01	57237002801	100 TABLET, FILM COATED in 1 BOTTLE (57237-028-01)	2005-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	REMEDYREPACK INC.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	7
Amoxicillin	NuCare Pharmaceuticals,Inc.	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	A-S Medication Solutions	2025-05-15	Human Prescription Drug Label	22
Amoxicillin	NuCare Pharmaceuticals, Inc.	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-08-21	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-07-07	Human Prescription Drug Label	10
Amoxicillin	RPK Pharmaceuticals, Inc.	2023-08-07	Human Prescription Drug Label	2
Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	2