Application 090354

Type: ANDA
Sponsor: ANTIBIOTICE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No
002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No

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
A090354-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28
A090354-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28
A090354-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28
A090354-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090354-001	AP
A090354-002	AP
A090354-003	AP
A090354-004	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	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090354-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090354-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090354-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090354-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090354-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090354-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090354-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090354-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090354-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090354-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090354-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090354-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090354-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090354-004	AP	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ampicillin	AMPICILLIN	Sagent Pharmaceuticals	9d2aebe8-4f04-49dd-b1e5-80b962868dc3	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090354 application number: ANDA090354 ndc (product): 25021-137 ndc (product): 25021-136
Ampicillin	AMPICILLIN	WG Critical Care, LLC	38ec7b7a-9caf-45f2-88a1-0f78f089a1e4	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090354 application number: ANDA090354
AMPICILLIN	AMPICILLIN INJECTION	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	302e6df7-37c5-4625-8a61-3e2f302addf2	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090354 application number: ANDA090354

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0463-1118	Ampicillin	Ampicillin sodium	C.O. Truxton, Inc.	ANDA	Current
25021-134	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-135	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-135	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-136	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-136	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-137	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
25021-137	ampicillin	ampicillin	Sagent Pharmaceuticals	ANDA	Current
36000-070	Ampicillin	ampicillin sodium	Claris Lifesciences, Inc.	ANDA	Current
36000-071	Ampicillin	Ampicillin sodium	Claris Lifesciences, Inc.	ANDA	Current
36000-072	Ampicillin	Ampicillin sodium	Claris Lifesciences, Inc.	ANDA	Current
36000-073	Ampicillin	Ampicillin sodium	Claris Lifesciences, Inc.	ANDA	Current
67850-021	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-021	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-021	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-021	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-022	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-022	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-022	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-022	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-023	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-023	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-023	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-023	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-024	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-024	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-024	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
67850-024	AMPICILLIN	Ampicillin Injection	Methapharm Inc.	ANDA	Current
70860-112	Ampicillin	ampicillin sodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-113	Ampicillin	ampicillin sodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-114	Ampicillin	ampicillin sodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-115	Ampicillin	ampicillin sodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71872-7151	Ampicillin	ampicillin sodium	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7169	Ampicillin	ampicillin sodium	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7204	AMPICILLIN	Ampicillin Injection	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7230	AMPICILLIN	Ampicillin Injection	Medical Purchasing Solutions, LLC	ANDA	Current