Amoxicillin

Product NDC: 70934-084
Requested package NDC: 70934-084-30
11-digit product format: 709340084
Labeler code: 70934
Product ID: 70934-084_b7df35e1-bc8d-736a-e053-2a95a90a75b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA062058
Marketing category: ANDA
Marketing start: 2018-03-05
Marketing end: 0000-00-00
Substance: AMOXICILLIN
Active strength: 500 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70934-084	70934-084-30	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 1 · 15 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A062058-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A062058-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062058-001	AB
A062058-002	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062058-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062058-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982	`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	A062058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062058-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062058-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062058-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062058-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062058-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062058-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062058-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062058-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062058-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062058-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062058-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062058-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062058-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062058-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062058-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062058-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062058-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062058-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062058-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062058-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062058-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062058-002	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
70934-084-21	2023-01-30	C162847	48780-1	f386c64a-1ee5-0266-e053-dadaa90a7c1a	Amoxicillin Capsules, USP 250 mg and 500 mg
70934-084-30	2023-01-30	C162847	48780-1	f386c64a-1ee5-0266-e053-dadaa90a7c1a	Amoxicillin Capsules, USP 250 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-084-21	Amoxicillin	21 in 1 BOTTLE, PLASTIC	CAPSULE	21		3
70934-084-30	Amoxicillin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-084	AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	3	Legacy NDC, 2 package rows	20210105_696ee0f7-9621-c832-e053-2991aa0a309b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	5002cce4-0abc-4446-888c-47396549d4da	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062058 application number: ANDA062058
Amoxicillin	AMOXICILLIN	Chartwell Governmental & Specialty RX, LLC	f9062321-ffb3-42e8-8f98-453cd30f5282	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062058 application number: ANDA062058

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	696ee0f7-9621-c832-e053-2991aa0a309b	3
308191	amoxicillin 500 MG Oral Capsule	SCD	696ee0f7-9621-c832-e053-2991aa0a309b	3
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	696ee0f7-9621-c832-e053-2991aa0a309b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-084-30	70934008430	30 CAPSULE in 1 BOTTLE, PLASTIC (70934-084-30)	30 capsule	2018-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin Capsules, USP 250 mg and 500 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin Capsules, USP 250 mg and 500 mg	REMEDYREPACK INC.	2018-04-12	HUMAN PRESCRIPTION DRUG LABEL	1