Ampicillin and Sulbactam

Product NDC: 0641-6116
Requested package NDC: 0641-6116-10
11-digit product format: 006416116
Labeler code: 0641
Product ID: 0641-6116_dcc2eac1-a1d3-4650-bbbc-5338dea664e4
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
Substance: AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength: 1; .5 g/1.5g; g/1.5g
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065406-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065406-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065406-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065406-002	AP	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Ampicillin and Sulbactam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPICILLIN SODIUM	1 g/1.5g
SULBACTAM SODIUM	.5 g/1.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JFN36L5S8K	Internal UNII lookup
DKQ4T82YE6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1659592	Internal RxNorm lookup
1659598	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d3026cc0-95d8-44cf-be47-b5ebb8fd4568	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6	Product name	1	20250722
1f6437d4-fe6e-4912-889c-84576c1da4d8	Product name	1	20231019
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3	Product name	2	20160201
c9385d77-2af7-47a4-bc97-1127e71caf9b	Product name	3	20160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815	Product name	5	20151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85	Product name	3	20151026
8c59be9b-72b0-49e8-b7ef-1a80c10599de	Product name	3	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6116-01	Ampicillin and Sulbactam	1.5 g in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1.5		10
0641-6116-10	Ampicillin and Sulbactam	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6116-01	EA - Each	0641-6116	b4cf2188-5d96-4b7d-8bc5-0d0c3f1af889	1	2012-07-24
0641-6116-10	EA - Each	0641-6116	aaf9f992-279d-44c9-995d-d236c0bc77f6	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6116	AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240926_d3026cc0-95d8-44cf-be47-b5ebb8fd4568.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 · 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 ndc (package): 0641-6116-10 ndc (product): 0641-6116 ndc11 (package): 00641611610

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659592	ampicillin / sulbactam 1.5 GM Injection	PSN	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659598	ampicillin / sulbactam 3 GM Injection	PSN	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659592	ampicillin 1000 MG / sulbactam 500 MG Injection	SCD	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659598	ampicillin 2000 MG / sulbactam 1000 MG Injection	SCD	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659592	ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection	SY	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659598	ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM Injection	SY	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659592	ampicillin 1 GM / sulbactam 0.5 GM Injection	SY	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10
1659598	ampicillin 2 GM / sulbactam 1 GM Injection	SY	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6116-10	00641611610	10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)	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 S.r.l.	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	11