Ampicillin

Product NDC: 67457-353
11-digit product format: 674570353
Labeler code: 67457
Product ID: 67457-353_43d50ba5-a7ba-464e-a6fa-deca84dfb670
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA201025
Marketing category: ANDA
Marketing start: 2016-10-06
Marketing end: 2022-04-30
Substance: AMPICILLIN SODIUM
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	67457-353		D	Discontinued by firm		2026-08-10
excluded package	package	67457-353	67457-353-10	D	Discontinued by firm		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 · 24 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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`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	67457-353-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201025-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09
A201025-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201025-003	AP
A201025-004	AP

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201025-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201025-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201025-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201025-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201025-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201025-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201025-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201025-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201025-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201025-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201025-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201025-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201025-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201025-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201025-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201025-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201025-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201025-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201025-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201025-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201025-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201025-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201025-004	AP	1	`4b0b4de00fa7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-353-10	EA - Each	67457-353	6fc383be-5b29-4779-a714-8c31c4a09284	1	2016-11-08
67457-353-25	EA - Each	67457-353	7a997d24-2022-4103-898e-81781b108d7b	1	2017-04-05

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin	AMPICILLIN	ONESOURCE SPECIALTY PHARMA LIMITED	519f2131-79e7-569f-e063-6394a90a2f93	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin sodium	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	402e7cc7-5ae8-c113-e063-6394a90aa54a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Armas Pharmaceuticals Inc.	34e95c91-3767-493c-8716-38e61e7c6674	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin sodium	AMPICILLIN	Civica, Inc.	2fd0f9fa-5b86-42f7-9a9f-767123638d39	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Medical Purchasing Solutions, LLC	29675d9c-3248-337a-e063-6294a90a2e20	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFN36L5S8K	AMPICILLIN SODIUM	69-52-3	AMPICILLIN SODIUM
7C782967RD	AMPICILLIN	69-53-4	Ampicillin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-353-10	67457035310	10 VIAL in 1 CARTON (67457-353-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (67457-353-25)	10 vial	2016-10-06	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)	Mylan Institutional LLC	2018-12-10	HUMAN PRESCRIPTION DRUG LABEL	8