AMOXICILLIN

Product NDC: 61919-016
11-digit product format: 619190016
Labeler code: 61919
Product ID: 61919-016_35bb9a75-990e-6515-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMOXICILLIN
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA062884
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 500 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-016		U	Excluded because listing certification expired	2026-08-17
excluded package	package	61919-016	61919-016-20	U	Excluded because listing certification expired	2026-08-17
excluded package	package	61919-016	61919-016-30	U	Excluded because listing certification expired	2026-08-17
excluded package	package	61919-016	61919-016-60	U	Excluded because listing certification expired	2026-08-17

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 2 · 88 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-016-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-016-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-016-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-016-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-016-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-016-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-016-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-016-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-016-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-016-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-016-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-016-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-016-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-016-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-016-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-016-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-016-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-016-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-016-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-016-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-016-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-016-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-016-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-016-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-016-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-016-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-016-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-016-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-016-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-016-60	`ad56d346431e…`	`cc804d4bbf1e…`
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	61919-016-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-016-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-016-60	`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	61919-016-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-016-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-016-60	`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	61919-016-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-016-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-016-60	`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	61919-016-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-016-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-016-60	`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	61919-016-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-016-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-016-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062884-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL			1988-02-25

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 2 · 42 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	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	1988-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062884-001	AMOXICILLIN	250MG	CAPSULE / ORAL		1988-02-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062884-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A062884-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062884-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062884-001	AB	1	`ea99ee380514…`

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
61919-016-20	AMOXICILLIN	20 in 1 BOTTLE	CAPSULE	20	5
61919-016-30	AMOXICILLIN	30 in 1 BOTTLE	CAPSULE	30	5
61919-016-60	AMOXICILLIN	60 in 1 BOTTLE	CAPSULE	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-016-20	EA - Each	61919-016	2e02c9e3-3e19-4194-b6bd-68765b9db644	1	2015-03-03
61919-016-30	EA - Each	61919-016	f2007a4c-c687-40df-8a33-500a56eee90d	1	2015-03-03
61919-016-60	EA - Each	61919-016	82be5a56-31bd-4050-8bb9-71ca4e9d4c47	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [DIRECT RX]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [DIRECT RX]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMOXICILLIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-016	AMOXICILLIN CAPSULE [DIRECT RX]	5	Legacy NDC, 3 package rows	20161018_8fbf98c5-0e34-46ab-bcef-b7c96b29200c.zip

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	8fbf98c5-0e34-46ab-bcef-b7c96b29200c	5
308191	amoxicillin 500 MG Oral Capsule	SCD	8fbf98c5-0e34-46ab-bcef-b7c96b29200c	5
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	8fbf98c5-0e34-46ab-bcef-b7c96b29200c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-016-20	61919001620	20 in 1 BOTTLE	Historical
61919-016-30	61919001630	30 in 1 BOTTLE	Historical
61919-016-60	61919001660	60 in 1 BOTTLE	Historical