Ampicillin and Sulbactam

Product NDC: 0641-6120
Requested package NDC: 0641-6120-10
11-digit product format: 006416120
Labeler code: 0641
Product ID: 0641-6120_92aca661-65af-4b86-a95c-ca9e2f7afd4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin and Sulbactam
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065406
Marketing category: ANDA
Marketing start: 2009-12-22
Marketing end: 0000-00-00
Substance: AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength: 2 g/3g; g/3g
Pharmacologic classes: beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0641-6120	0641-6120-10	D	Discontinued by firm		2026-08-03

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A065406-001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2009-12-22
A065406-002	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2009-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065406-001	AP
A065406-002	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 3 · 82 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	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065406-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065406-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065406-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065406-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065406-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065406-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065406-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065406-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065406-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065406-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065406-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065406-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065406-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065406-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065406-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065406-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065406-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065406-002	AP	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6120-10	2025-03-12	C162847	48780-1	2cef2736-82c7-d83d-e063-dadaa90ab31f	AMPICILLIN AND SULBACTAM FOR INJECTION, USP
0641-6120-10	2025-01-30	C162847	48780-1	2cef2736-82c7-d83d-e063-dadaa90ab31f	AMPICILLIN AND SULBACTAM FOR INJECTION, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6120-01	EA - Each	0641-6120	48bef9ab-977e-4bf9-a18a-168fa40b5e19	1	2012-07-24
0641-6120-10	EA - Each	0641-6120	e82ec28b-e40f-40f7-8215-f15a4c5e6a36	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMPICILLIN SODIUM	ACTIVE INGREDIENT	JFN36L5S8K	AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]	4
SULBACTAM SODIUM	ACTIVE INGREDIENT	DKQ4T82YE6	AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]	4
AMPICILLIN	ACTIVE MOIETY	7C782967RD	AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]	4
SULBACTAM	ACTIVE MOIETY	S4TF6I2330	AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]	4

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406
ampicillin and sulbactam	AMPICILLIN AND SULBACTAM	Sagent Pharmaceuticals	a67ae347-487d-4751-a841-b321e81db26f	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Hikma Pharmaceuticals USA Inc.	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFN36L5S8K	AMPICILLIN SODIUM	69-52-3	AMPICILLIN SODIUM
DKQ4T82YE6	SULBACTAM SODIUM	69388-84-7	SULBACTAM SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6120-10	00641612010	10 VIAL in 1 CARTON (0641-6120-10) > 3 g in 1 VIAL (0641-6120-01)	10 vial	2009-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMPICILLIN AND SULBACTAM FOR INJECTION, USP	Hikma Pharmaceuticals USA Inc. \| MITIM SRL	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	5