UNASYN

Product NDC: 0049-0024
Requested package NDC: 0049-0024-28
11-digit product format: 000490024
Labeler code: 0049
Product ID: 0049-0024_f96b8c10-d100-47bd-9c4a-3bcce67b1758
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ampicillin sodium and sulbactam sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Roerig
Application: NDA050608
Marketing category: NDA
Marketing start: 1991-11-22
Substance: AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength: 100; 50 mg/mL; mg/mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0049-0024	0049-0024-28	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N050608-001	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31
N050608-002	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31
N050608-003	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31
N050608-005	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N050608-001	AP
N050608-002	AP
N050608-005	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N050608-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050608-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050608-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050608-001	AP	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: UNASYN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPICILLIN SODIUM	100 mg/mL
SULBACTAM SODIUM	50 mg/mL

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
205843	Internal RxNorm lookup
240984	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
12eeb72a-403d-41be-bae4-4cb930862884	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
0049-0024-28	UNASYN	100 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, FOR SOLUTION	100		39
0049-0024-28	UNASYN	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0049-0024-28	EA - Each	0049-0024	5e7bb887-44d6-423d-9fd6-5733a99b4773	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMPICILLIN SODIUM	ACTIVE INGREDIENT	JFN36L5S8K	UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]	16
SULBACTAM SODIUM	ACTIVE INGREDIENT	DKQ4T82YE6	UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]	16
AMPICILLIN	ACTIVE MOIETY	7C782967RD	UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]	16
SULBACTAM	ACTIVE MOIETY	S4TF6I2330	UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0049-0024	UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]	39	Current NDC, Legacy NDC, 2 package rows	20250515_12eeb72a-403d-41be-bae4-4cb930862884.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UNASYN	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Roerig	155c7ec0-5862-404f-b1d0-f278f8a8bbda	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050608 application number: NDA050608
UNASYN	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Roerig	12eeb72a-403d-41be-bae4-4cb930862884	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050608 application number: NDA050608 ndc (package): 0049-0024-28 ndc (product): 0049-0024 ndc11 (package): 00049002428

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
240984	ampicillin 100 MG / sulbactam 50 MG in ML Injectable Solution	PSN	12eeb72a-403d-41be-bae4-4cb930862884	39
205843	Unasyn (ampicillin 100 MG / sulbactam 50 MG) per ML Injectable Solution	PSN	12eeb72a-403d-41be-bae4-4cb930862884	39
205843	ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution [Unasyn]	SBD	12eeb72a-403d-41be-bae4-4cb930862884	39
240984	ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution	SCD	12eeb72a-403d-41be-bae4-4cb930862884	39
240984	ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution	SY	12eeb72a-403d-41be-bae4-4cb930862884	39
240984	ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable Solution	SY	12eeb72a-403d-41be-bae4-4cb930862884	39
205843	Unasyn (ampicillin 100 MG / sulbactam 50 MG) per ML Injectable Solution	SY	12eeb72a-403d-41be-bae4-4cb930862884	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0049-0024-28	00049002428	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	1991-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UNASYN (ampicillin and sulbactam) for injection, USP	Roerig \| Pharmacia & Upjohn Company LLC	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	40