AMPICILLIN

Product NDC: 67850-023
Requested package NDC: 67850-023-10
11-digit product format: 678500023
Labeler code: 67850
Product ID: 67850-023_8d1c1c38-c673-4a99-9a6b-f546c0379c5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin Injection
Dosage form: POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Methapharm Inc.
Application: ANDA090354
Marketing category: ANDA
Marketing start: 2019-03-06
Marketing end: 0000-00-00
Substance: AMPICILLIN SODIUM
Active strength: 250 mg/250mg
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	67850-023	67850-023-10	D	Discontinued by firm		2026-08-11

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67850-023	AMPICILLIN (AMPICILLIN INJECTION) POWDER, FOR SOLUTION [METHAPHARM INC.]	9	Legacy NDC	20241207_3f6275f9-ee6f-4087-b672-5611d6870558.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 · 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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFN36L5S8K	AMPICILLIN SODIUM	69-52-3	AMPICILLIN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67850-023-10	67850002310	10 VIAL in 1 PACKAGE (67850-023-10) > 250 mg in 1 VIAL (67850-023-00)	10 vial	2019-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin Injection - Methapharm Inc.	Methapharm Inc.	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	9