Amoxicillin

Product NDC: 0143-9939
11-digit product format: 001439939
Labeler code: 0143
Product ID: 0143-9939_3dff1b4d-37d9-4573-b2c1-039b4686283f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065291
Marketing category: ANDA
Marketing start: 2007-03-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9939	0143-9939-20	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9939	0143-9939-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065291-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		2007-02-05
A065291-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		2007-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065291-001	AB
A065291-002	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	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2007-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2007-02-05	`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	A065291-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065291-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065291-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065291-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065291-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065291-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065291-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065291-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065291-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065291-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065291-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065291-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065291-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065291-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065291-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065291-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065291-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065291-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065291-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065291-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065291-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065291-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065291-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065291-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065291-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065291-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065291-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065291-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065291-002	AB	1	`bb7c543d1eb4…`

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
4fb7837e-964c-4d38-a3a5-b384b1bd6e08	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
0143-9939-05	Amoxicillin	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	22
0143-9939-28	Amoxicillin	480 in 1 BOTTLE, PLASTIC	CAPSULE	480	22
0143-9938-01	Amoxicillin	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	1
0143-9939-05	Amoxicillin	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	1
0143-9939-20	Amoxicillin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9939-01	EA - Each	0143-9939	51d523fc-0290-49a4-b636-3b4aa604f33e	1	2012-07-24
0143-9939-05	EA - Each	0143-9939	edc2c7ee-048e-4c7a-a401-a5b9ea2efd85	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	7
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
Amoxicillin	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
Amoxicillin	ACTIVE MOIETY	804826J2HU	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
Croscarmellose sodium	INACTIVE INGREDIENT		AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1
Yellow Iron Oxide	INACTIVE INGREDIENT		AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9939	AMOXICILLIN CAPSULE [HIKMA PHARMACEUTICALS USA INC.]	20	Current NDC, Legacy NDC, 2 package rows	20240821_4fb7837e-964c-4d38-a3a5-b384b1bd6e08.zip
0143-9939	AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]	1	Current NDC, Legacy NDC, 3 package rows	20080505_de8990a6-f3b6-478f-acbe-eda961b6da4b.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	18a4f555-a537-4c40-9bb2-dc3bd782fa27	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	96057ce7-9516-4239-9974-5e9691b44c9b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291 ndc (product): 0143-9939
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	039d2677-b04f-436c-e063-6294a90ac519	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	fd071263-b750-4831-9fc5-de112a5f685b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	b988349d-2198-4dbb-a231-9ba37262ce28	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	364f969d-3037-4dff-b04b-304bca27442e	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	521f7a05-4e6d-447f-b38e-00c4d623703b	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065291 application number: ANDA065291

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	b988349d-2198-4dbb-a231-9ba37262ce28	38
308191	amoxicillin 500 MG Oral Capsule	SCD	b988349d-2198-4dbb-a231-9ba37262ce28	38
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	b988349d-2198-4dbb-a231-9ba37262ce28	38
308191	amoxicillin 500 MG Oral Capsule	PSN	521f7a05-4e6d-447f-b38e-00c4d623703b	29
308191	amoxicillin 500 MG Oral Capsule	SCD	521f7a05-4e6d-447f-b38e-00c4d623703b	29
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	521f7a05-4e6d-447f-b38e-00c4d623703b	29
308191	amoxicillin 500 MG Oral Capsule	PSN	364f969d-3037-4dff-b04b-304bca27442e	27
308191	amoxicillin 500 MG Oral Capsule	SCD	364f969d-3037-4dff-b04b-304bca27442e	27
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	364f969d-3037-4dff-b04b-304bca27442e	27
308191	amoxicillin 500 MG Oral Capsule	PSN	96057ce7-9516-4239-9974-5e9691b44c9b	26
308191	amoxicillin 500 MG Oral Capsule	SCD	96057ce7-9516-4239-9974-5e9691b44c9b	26
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	96057ce7-9516-4239-9974-5e9691b44c9b	26
308191	amoxicillin 500 MG Oral Capsule	PSN	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	22
308191	amoxicillin 500 MG Oral Capsule	SCD	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	22
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	22
308191	amoxicillin 500 MG Oral Capsule	PSN	039d2677-b04f-436c-e063-6294a90ac519	21
308191	amoxicillin 500 MG Oral Capsule	SCD	039d2677-b04f-436c-e063-6294a90ac519	21
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	039d2677-b04f-436c-e063-6294a90ac519	21
308191	amoxicillin 500 MG Oral Capsule	PSN	18a4f555-a537-4c40-9bb2-dc3bd782fa27	20
308191	amoxicillin 500 MG Oral Capsule	SCD	18a4f555-a537-4c40-9bb2-dc3bd782fa27	20
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	18a4f555-a537-4c40-9bb2-dc3bd782fa27	20
308191	amoxicillin 500 MG Oral Capsule	PSN	fd071263-b750-4831-9fc5-de112a5f685b	16
308191	amoxicillin 500 MG Oral Capsule	SCD	fd071263-b750-4831-9fc5-de112a5f685b	16
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	fd071263-b750-4831-9fc5-de112a5f685b	16
308191	amoxicillin 500 MG Oral Capsule	PSN	a61e4152-48e9-6b40-e053-2995a90a6aad	5
308191	amoxicillin 500 MG Oral Capsule	SCD	a61e4152-48e9-6b40-e053-2995a90a6aad	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	a61e4152-48e9-6b40-e053-2995a90a6aad	5
308191	amoxicillin 500 MG Oral Capsule	PSN	8b256346-944f-54b5-e053-2995a90ae259	2
308191	amoxicillin 500 MG Oral Capsule	PSN	3afc3097-a757-49a0-aaec-85ac267aabb1	2
308191	amoxicillin 500 MG Oral Capsule	PSN	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2
308191	amoxicillin 500 MG Oral Capsule	SCD	3afc3097-a757-49a0-aaec-85ac267aabb1	2
308191	amoxicillin 500 MG Oral Capsule	SCD	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2
308191	amoxicillin 500 MG Oral Capsule	SCD	8b256346-944f-54b5-e053-2995a90ae259	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	8b256346-944f-54b5-e053-2995a90ae259	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	3afc3097-a757-49a0-aaec-85ac267aabb1	2
308182	amoxicillin 250 MG Oral Capsule	PSN	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1
308191	amoxicillin 500 MG Oral Capsule	PSN	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1
308182	amoxicillin 250 MG Oral Capsule	SCD	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1
308191	amoxicillin 500 MG Oral Capsule	SCD	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9938-01	00143993801	100 in 1 BOTTLE, PLASTIC						Historical
0143-9939-01	00143993901	100 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-01)	100 capsule	2007-03-01	0000-00-00	No	No	Current
0143-9939-05	00143993905	500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-05)	500 capsule	2007-03-01	0000-00-00	No	No	Current
0143-9939-20	00143993920	20 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-20)	20 capsule	2007-03-01	0000-00-00	No	No	Current
0143-9939-28	00143993928	480 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-28)	480 capsule	2026-04-22		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	21
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	27
Amoxicillin	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC	2026-03-01	HUMAN PRESCRIPTION DRUG LABEL	23
Amoxicillin - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	21
Amoxicillin	REMEDYREPACK INC.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	A-S Medication Solutions	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	16
Amoxicillin	A-S Medication Solutions	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	38
Amoxicillin	A-S Medication Solutions	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	29
Amoxicillin	A-S Medication Solutions	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	27
Amoxicillin 500mg	RedPharm Drug, Inc. \| RedPharm Drug	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2023-09-05	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2021-12-07	HUMAN PRESCRIPTION DRUG LABEL	13
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg	Lake Erie Medical DBA Quality Care Products LLC \| Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2021-10-19	HUMAN PRESCRIPTION DRUG LABEL	12
Amoxicillin - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg	Blenheim Pharmacal, Inc.	2010-10-18	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg	Altura Pharmaceuticals, Inc.	2010-04-28	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg	West-ward Pharmaceutical Corp.	2008-04-04	HUMAN PRESCRIPTION DRUG LABELING	1