Amoxicillin

Product NDC: 50090-1794
11-digit product format: 500901794
Labeler code: 50090
Product ID: 50090-1794_0061b41b-511d-4a65-affb-80988a0602d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
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

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-7	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1794-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1794-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1794-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1794-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1794-2	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	2005-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	2005-11-09	`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	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…`
2022-03-09 01:35 UTC	2022-03	A065271-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065271-002	AB	1	`bb7c543d1eb4…`

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 · 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
e13cafe2-f226-4021-81d8-7bd1f98b5582	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1794-0	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-1	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-2	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-5	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-7	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-8	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-9	2024-11-04	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-0	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-1	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-2	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-5	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-7	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-8	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
50090-1794-9	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-1794-0	Amoxicillin	30 in 1 BOTTLE	CAPSULE	30	12
50090-1794-1	Amoxicillin	40 in 1 BOTTLE	CAPSULE	40	12
50090-1794-2	Amoxicillin	21 in 1 BOTTLE	CAPSULE	21	12
50090-1794-5	Amoxicillin	15 in 1 BOTTLE	CAPSULE	15	12
50090-1794-7	Amoxicillin	10 in 1 BOTTLE	CAPSULE	10	12
50090-1794-8	Amoxicillin	9 in 1 BOTTLE	CAPSULE	9	12
50090-1794-9	Amoxicillin	42 in 1 BOTTLE	CAPSULE	42	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1794-0	EA - Each	50090-1794	a6e4c4ac-ab59-450b-a6fe-383065f06bd4	1	2021-09-07
50090-1794-1	EA - Each	50090-1794	ae516254-633b-4e2a-8cdc-be5ad5348f70	1	2021-09-07
50090-1794-2	EA - Each	50090-1794	7a1f16c5-23b2-439a-8afc-50e659a74eb1	1	2021-04-08
50090-1794-5	EA - Each	50090-1794	fb866719-8aad-4c5d-9b70-3645cf5c97d3	1	2021-09-07
50090-1794-7	EA - Each	50090-1794	85199c04-a380-4c72-a4c4-4e1c3c7ef683	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1794	AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS]	12	Current NDC, Legacy NDC, 7 package rows	20241105_e13cafe2-f226-4021-81d8-7bd1f98b5582.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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Redpharm Drug	57f5652d-ee50-eb7e-e063-6394a90a7b66	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Redpharm Drug	57e56202-950b-10f6-e063-6394a90a4912	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	1d0d8bc4-137e-ef10-e063-6294a90acf62	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	53548597-347b-42a9-916c-e88cd27b8dcd	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ef03286b-4ba7-4952-9ab1-90cacf300504	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5155ca5d-fe58-42b4-e063-6394a90ab135	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin 500 mg	AMOXICILLIN	Health Department, Oklahoma State	f049551b-4708-eb13-e053-2a95a90afd1f	2025-12-13		Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	32b224c2-1354-4b58-b082-b93330e6962b	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065271 application number: ANDA065271
Amoxicillin	AMOXICILLIN	QPharma Inc	2772a745-1276-405b-b229-95edf5534b2a	2025-12-05	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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1794-0	50090179400	30 CAPSULE in 1 BOTTLE (50090-1794-0)	30 capsule	2015-04-29	0000-00-00	No	No	Current
50090-1794-1	50090179401	40 CAPSULE in 1 BOTTLE (50090-1794-1)	40 capsule	2015-04-29	0000-00-00	No	No	Current
50090-1794-2	50090179402	21 CAPSULE in 1 BOTTLE (50090-1794-2)	21 capsule	2015-04-29	0000-00-00	No	No	Current
50090-1794-5	50090179405	15 CAPSULE in 1 BOTTLE (50090-1794-5)	15 capsule	2015-04-29	0000-00-00	No	No	Current
50090-1794-7	50090179407	10 CAPSULE in 1 BOTTLE (50090-1794-7)	10 capsule	2020-04-28	0000-00-00	No	No	Current
50090-1794-8	50090179408	9 CAPSULE in 1 BOTTLE (50090-1794-8)	9 capsule	2015-04-29	0000-00-00	No	No	Current
50090-1794-9	50090179409	42 CAPSULE in 1 BOTTLE (50090-1794-9)	42 capsule	2015-04-29	0000-00-00	No	No	Current