Amoxicillin

Product NDC: 65862-016
Requested package NDC: 65862-016-22
11-digit product format: 658620016
Labeler code: 65862
Product ID: 65862-016_4dc94f3c-990d-476f-a88e-df9967570eec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065271
Marketing category: ANDA
Marketing start: 2005-11-09
Substance: AMOXICILLIN
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-016	65862-016-22	UNFINISHED	Active or certified unfinished drug listing		2026-10-15

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065271-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065271-002	AB	1	`c2088c7a36db…`
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…`

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	250 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
7e3a4517-1934-4e03-b96b-4ad65ab076c5	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
65862-016-01	Amoxicillin	100 in 1 BOTTLE	CAPSULE	100	20
65862-016-05	Amoxicillin	500 in 1 BOTTLE	CAPSULE	500	20
65862-016-20	Amoxicillin	20 in 1 BOTTLE	CAPSULE	20	20
65862-016-30	Amoxicillin	30 in 1 BOTTLE	CAPSULE	30	20
65862-016-50	Amoxicillin	50 in 1 BOTTLE	CAPSULE	50	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-016-01	EA - Each	65862-016	a3852356-d164-4277-96b2-73a7e54c7186	1	2012-07-24
65862-016-05	EA - Each	65862-016	0f36be81-af4b-4f37-915a-941fdbe359f0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	12
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [STAT RX USA LLC]	2
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [APOTHECA INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-016	AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]	20	Current NDC, Legacy NDC, 5 package rows	20240203_7e3a4517-1934-4e03-b96b-4ad65ab076c5.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 4 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Proficient Rx LP	66404ced-5ef4-4a31-9276-8c6f86add61c	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Proficient Rx LP	2c395111-c9c1-483e-a542-58b935ede689	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	fe9e12de-9be9-4211-9a58-c7ecd9e838d5	2022-11-02	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	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308191	amoxicillin 500 MG Oral Capsule	PSN	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308182	amoxicillin 250 MG Oral Capsule	SCD	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308191	amoxicillin 500 MG Oral Capsule	SCD	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	7e3a4517-1934-4e03-b96b-4ad65ab076c5	20
308182	amoxicillin 250 MG Oral Capsule	PSN	8f8b1fe6-23cb-2105-e053-2a95a90aeede	5
308182	amoxicillin 250 MG Oral Capsule	SCD	8f8b1fe6-23cb-2105-e053-2a95a90aeede	5
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	8f8b1fe6-23cb-2105-e053-2a95a90aeede	5
308182	amoxicillin 250 MG Oral Capsule	PSN	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308191	amoxicillin 500 MG Oral Capsule	PSN	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308182	amoxicillin 250 MG Oral Capsule	SCD	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308191	amoxicillin 500 MG Oral Capsule	SCD	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	f884225c-7845-4df1-ba35-dc53010ed0b0	4
308182	amoxicillin 250 MG Oral Capsule	PSN	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308182	amoxicillin 250 MG Oral Capsule	PSN	fc61c9f5-b0f8-3ff8-e053-6394a90adeb7	2
308191	amoxicillin 500 MG Oral Capsule	PSN	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308182	amoxicillin 250 MG Oral Capsule	SCD	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308182	amoxicillin 250 MG Oral Capsule	SCD	fc61c9f5-b0f8-3ff8-e053-6394a90adeb7	2
308191	amoxicillin 500 MG Oral Capsule	SCD	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	fc61c9f5-b0f8-3ff8-e053-6394a90adeb7	2
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	78cabf7c-f342-4285-bc5a-9f24789d44ed	2
308182	amoxicillin 250 MG Oral Capsule	PSN	1c755ad7-f0a8-4a63-a686-413bae57f8d0	1
308182	amoxicillin 250 MG Oral Capsule	PSN	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1
308182	amoxicillin 250 MG Oral Capsule	PSN	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308182	amoxicillin 250 MG Oral Capsule	PSN	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308191	amoxicillin 500 MG Oral Capsule	PSN	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1
308191	amoxicillin 500 MG Oral Capsule	PSN	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308191	amoxicillin 500 MG Oral Capsule	PSN	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308182	amoxicillin 250 MG Oral Capsule	SCD	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1
308182	amoxicillin 250 MG Oral Capsule	SCD	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308182	amoxicillin 250 MG Oral Capsule	SCD	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308182	amoxicillin 250 MG Oral Capsule	SCD	1c755ad7-f0a8-4a63-a686-413bae57f8d0	1
308191	amoxicillin 500 MG Oral Capsule	SCD	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308191	amoxicillin 500 MG Oral Capsule	SCD	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308191	amoxicillin 500 MG Oral Capsule	SCD	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	1c755ad7-f0a8-4a63-a686-413bae57f8d0	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	b41ecd6b-4c54-44c8-aa3f-1868faad07c6	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec	1
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-016-22	65862001622	2000 CAPSULE in 1 BAG (65862-016-22)	2000 capsule	11-SEP-05	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	NuCare Pharmaceuticals,Inc.	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	6
Amoxicillin	Bryant Ranch Prepack	2025-06-20	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	Redpharm Drug	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin	Aurobindo Pharma Limited	2024-01-23	Human Prescription Drug Label	20
Amoxicillin	A-S Medication Solutions	2023-02-04	Human Prescription Drug Label	8
Amoxicillin	Apotheca Inc.	2016-06-13	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin	Aidarex Pharmaceuticals LLC	2012-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
AMOXICILLIN	STAT Rx USA LLC \| PSS World Medical Inc.	2012-06-07	Human Prescription Drug Label	2
Amoxicillin Capsules, USP	Rebel Distributors Corp.	2009-12-01	Human Prescription Drug Label	1