Amoxicillin

Product NDC: 21695-385
11-digit product format: 216950385
Labeler code: 21695
Product ID: 21695-385_61b292ba-a739-444d-896e-be204bfd9a1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA061931
Marketing category: ANDA
Marketing start: 2010-02-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 250 mg/5mL
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	21695-385		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-385	21695-385-00	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-385	21695-385-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-385	21695-385-80	I	Inactivated by FDA	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	21695-385-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-385-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-385-15	`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	21695-385-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-385-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-385-15	`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	21695-385-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-385-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-385-15	`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	21695-385-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-385-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-385-15	`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	21695-385-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-385-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-385-15	`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	21695-385-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-385-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-385-15	`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	21695-385-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-385-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-385-15	`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	21695-385-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-385-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-385-15	`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	21695-385-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-385-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-385-15	`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	21695-385-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-385-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-385-15	`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	21695-385-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-385-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-385-15	`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	21695-385-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-385-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-385-15	`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	21695-385-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-385-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-385-15	`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	21695-385-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-385-00	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-385-15	`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	21695-385-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-385-00	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-385-15	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A061931-001	AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982
A061931-002	AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982
A061931-003	AMOXICILLIN PEDIATRIC	AMOXICILLIN	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061931-002	AB
A061931-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-002	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-003	AMOXICILLIN PEDIATRIC	50MG/ML	FOR SUSPENSION / ORAL	AB		1982-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-001	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL		Approved before 1982		`1e350fbaab3a…`

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	A061931-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061931-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061931-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061931-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061931-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061931-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061931-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061931-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061931-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061931-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061931-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061931-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061931-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061931-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061931-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061931-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061931-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061931-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061931-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061931-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061931-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061931-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061931-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061931-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061931-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061931-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061931-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061931-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061931-003	AB	1	`bb7c543d1eb4…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-385-00	2019-09-24	C162847	48780-1	934fe258-485a-48b1-e053-8cdaa90a720a	AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL 4150 4155 Rx only
21695-385-15	2019-09-24	C162847	48780-1	934fe258-485a-48b1-e053-8cdaa90a720a	AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL 4150 4155 Rx only
21695-385-80	2019-09-24	C162847	48780-1	934fe258-485a-48b1-e053-8cdaa90a720a	AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL 4150 4155 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-385-00	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	1
21695-385-15	Amoxicillin	150 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	150	1
21695-385-80	Amoxicillin	80 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	80	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-385-00	ML - Milliliter	21695-385	dd3e8f24-011e-46c6-a9aa-3485d6fd3bb3	1	2012-07-24
21695-385-15	ML - Milliliter	21695-385	464ea112-3853-452d-8be7-e11fb2c86946	1	2012-07-24
21695-385-80	ML - Milliliter	21695-385	51bad023-b4cf-48af-9ef6-2fffc973289f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-385	AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 3 package rows	20100225_e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	cf707c13-3b40-079c-e053-2995a90a2176	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	5780c9e4-5e22-270c-e053-2a91aa0a36ba	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	bfd67724-fb22-4eac-8ebd-555614c16329	2023-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931
Amoxicillin	AMOXICILLIN	Proficient Rx LP	de792ac6-4b3d-4d34-8e50-030b5bd830d7	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061931 application number: ANDA061931

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
313797	amoxicillin 125 MG in 5 mL Oral Suspension	PSN	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
313797	amoxicillin 25 MG/ML Oral Suspension	SCD	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
313797	amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension	SY	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
313797	amoxicillin 125 MG per 5 ML Oral Suspension	SY	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-385-00	21695038500	100 mL in 1 BOTTLE	100 ml	Historical
21695-385-15	21695038515	150 mL in 1 BOTTLE	150 ml	Historical
21695-385-80	21695038580	80 mL in 1 BOTTLE	80 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL 4150 4155 Rx only	Rebel Distributors Corp.	2010-02-01	HUMAN PRESCRIPTION DRUG LABEL	1