AMOXICILLIN

Manufacturer: DIRECTRX | DIRECT RX
Effective date: 2016-04-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:22:11

Label at a glance#

ProductAMOXICILLIN

Active ingredientAMOXICILLIN

Label structure1 sections

Label contents#

Full prescribing information#

500 mg Capsule Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMOXICILLIN 500mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308191	amoxicillin 500 MG Oral Capsule	PSN	1
308191	amoxicillin 500 MG Oral Capsule	SCD	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AMOXICILLIN ANHYDROUS Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-355-30	2020-01-31	C162847	48780-1	9d75b9d0-4bb8-f424-e053-dadaa90a57ce	AMOXICILLIN 500mg 30 TABS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-355-30	AMOXICILLIN	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-355	AMOXICILLIN CAPSULE [DIRECTRX]	1	Legacy NDC, 1 package rows	20160414_30635424-e6bc-1bff-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-355-20	EA - Each	61919-355	a0b7f717-bf2e-4730-8d4e-2302f46c0fa2	1	2018-03-08
61919-355-30	EA - Each	61919-355	e2c97253-47ab-4816-8d41-a831f51a7941	1	2016-09-02
67253-150-10	EA - Each	67253-150	09899cd2-2e67-4686-b9a3-f638700b3f66	1	2015-09-10
67253-150-50	EA - Each	67253-150	49cb1930-a055-48a3-b014-5fd6ac6f1954	1	2015-09-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

AMOXICILLIN
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
WATER
CELLULOSE, MICROCRYSTALLINE
SHELLAC
AMMONIA
AMOXICILLIN ANHYDROUS
FERROSOFERRIC OXIDE
ALCOHOL
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-355	61919-355-30
67253-150

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOPROPYL ALCOHOL	ND2M416302	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
AMMONIA	5138Q19F1X	IACT
AMOXICILLIN	804826J2HU	ACTIM
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ALCOHOL	3K9958V90M	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
GELATIN	2G86QN327L	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A064076-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		1994-09-30
A064076-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		1994-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064076-001	AB
A064076-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 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	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1994-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	1994-09-30	`74a2ff9319b5…`

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	A064076-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A064076-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064076-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064076-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064076-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064076-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064076-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064076-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064076-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064076-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064076-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064076-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064076-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064076-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064076-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064076-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064076-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064076-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064076-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064076-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064076-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064076-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064076-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064076-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064076-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064076-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064076-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064076-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064076-002	AB	1	`74a2ff9319b5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
30635424-e6bd-1bff-e054-00144ff88e88			30635424-e6bc-1bff-e054-00144ff88e88	2016-04-13	Warnings, Adverse reactions	Exact identifier spl id: 30635424-e6bd-1bff-e054-00144ff88e88 spl set id: 30635424-e6bc-1bff-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.