Ampicillin

Product NDC: 70594-084
11-digit product format: 705940084
Labeler code: 70594
Product ID: 70594-084_2c29bd08-f467-4028-aac6-0a5b3007a5d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMPICILLIN SODIUM
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Xellia Pharmaceuticals USA LLC
Application: ANDA090583
Marketing category: ANDA
Marketing start: 2021-01-10
Marketing end: 0000-00-00
Substance: AMPICILLIN SODIUM
Active strength: 250 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	70594-084		D	Discontinued by firm		2026-10-20
excluded package	package	70594-084	70594-084-02	D	Discontinued by firm		2026-10-20

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 · 4 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
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	70594-084-02	`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	70594-084-02	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090583-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27
A090583-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27
A090583-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27
A090583-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27
A090583-005	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090583-001	AP
A090583-002	AP
A090583-003	AP
A090583-004	AP
A090583-005	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 6 · 220 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
2026-10-15 13:18:30	2026-09	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090583-001	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090583-002	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090583-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090583-004	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090583-005	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-11-27	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A090583-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090583-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090583-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090583-004	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090583-005	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090583-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090583-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090583-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090583-004	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090583-005	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090583-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090583-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090583-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090583-004	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090583-005	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090583-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090583-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090583-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090583-004	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090583-005	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090583-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090583-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090583-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090583-004	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090583-005	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090583-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090583-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090583-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090583-004	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090583-005	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090583-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090583-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090583-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090583-004	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090583-005	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090583-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090583-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090583-003	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090583-004	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090583-005	AP	1	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70594-084-02	2024-12-10	C162847	48780-1	1030e365-2858-111a-e063-dadaa90a10e2	Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)
70594-084-02	2024-07-30	C162847	48780-1	1030e365-2858-111a-e063-dadaa90a10e2	Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)
70594-084-02	2024-01-30	C162847	48780-1	1030e365-2858-111a-e063-dadaa90a10e2	Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-084-01	EA - Each	70594-084	08e1b0e2-40de-4267-ac60-f987639401c7	1	2021-12-08
70594-084-02	EA - Each	70594-084	40ae0702-0b84-4ddd-b149-0d3d788e9372	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-084	AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	2	Legacy NDC	20241212_94421dac-7865-49f8-ae52-871eee6465ac.zip

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
70594-084-02	70594008402	10 VIAL in 1 CARTON (70594-084-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-084-01)	10 vial	2021-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampicillin for Injection, USP (For Intramuscular or Intravenous Injection)	Xellia Pharmaceuticals USA LLC	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	2