Ampicillin

Product NDC: 70934-417
11-digit product format: 709340417
Labeler code: 70934
Product ID: 70934-417_d2187307-632d-6484-e053-2a95a90a8b1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA064082
Marketing category: ANDA
Marketing start: 2019-08-06
Marketing end: 0000-00-00
Substance: AMPICILLIN TRIHYDRATE
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70934-417		I	Inactivated by FDA		2026-08-10
excluded package	package	70934-417	70934-417-28	I	Inactivated by FDA		2026-08-10

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 · 30 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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`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	70934-417-28	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A064082-001	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29
A064082-002	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064082-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064082-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A064082-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064082-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064082-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A064082-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064082-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A064082-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064082-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064082-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064082-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064082-002	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A064082-002	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6	Product name	1	20250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3	Product name	2	20160201
c9385d77-2af7-47a4-bc97-1127e71caf9b	Product name	3	20160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815	Product name	5	20151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85	Product name	3	20151026
8c59be9b-72b0-49e8-b7ef-1a80c10599de	Product name	3	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-417-28	2023-01-30	C162847	48780-1	f386c64a-1682-0266-e053-dadaa90a7c1a	Ampicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-417-28	Ampicillin	28 in 1 BOTTLE, PLASTIC	CAPSULE	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-417	AMPICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20211230_90b8409e-2460-0cb7-e053-2995a90a3110.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
Ampicillin	AMPICILLIN	REMEDYREPACK INC.	4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082
Ampicillin	AMPICILLIN	Sandoz Inc	0a66c5c3-63bf-46e3-835e-26b555ab6954	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HXQ6A1N7R6	AMPICILLIN TRIHYDRATE	7177-48-2	AMPICILLIN TRIHYDRATE
7C782967RD	AMPICILLIN	69-53-4	Ampicillin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308212	ampicillin 500 MG Oral Capsule	PSN	90b8409e-2460-0cb7-e053-2995a90a3110	3
308212	ampicillin 500 MG Oral Capsule	SCD	90b8409e-2460-0cb7-e053-2995a90a3110	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-417-28	70934041728	28 CAPSULE in 1 BOTTLE, PLASTIC (70934-417-28)	28 capsule	2019-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin Capsules, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-12-01	HUMAN PRESCRIPTION DRUG LABEL	3