UNASYN

Product NDC
0049-0014
11-digit product format
000490014
Labeler code
0049
Product ID
0049-0014_6b0299f2-a683-4c8f-bf62-b79d5f652b41
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
2; 1 g/1; g/1
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050608-001UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31
N050608-002UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31
N050608-003UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31
N050608-005UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050608-001AP
N050608-002AP
N050608-005AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050608-001UNASYNEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050608-002UNASYNEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050608-003UNASYNEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTION1986-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050608-005UNASYNEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1993-12-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050608-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050608-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050608-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050608-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050608-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050608-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050608-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050608-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050608-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050608-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050608-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050608-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050608-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050608-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050608-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050608-005AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050608-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050608-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050608-005AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050608-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050608-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050608-005AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050608-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050608-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050608-005AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050608-001AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM2 g/1
SULBACTAM SODIUM1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DKQ4T82YE6Internal UNII lookup
JFN36L5S8KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659592Internal RxNorm lookup
1659595Internal RxNorm lookup
1659598Internal RxNorm lookup
1659600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
155c7ec0-5862-404f-b1d0-f278f8a8bbdaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
1f6437d4-fe6e-4912-889c-84576c1da4d8Product name120231019
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-0014-81UNASYN1 in 1 VIALINJECTION, POWDER, FOR SOLUTION145
0049-0014-83UNASYN10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0014-81EA - Each0049-0014dc9b2812-ee90-43ed-a007-39f6d5a8a69812015-07-20
0049-0014-83EA - Each0049-0014e0765e9d-59b8-4c66-be1e-5ec2c3f1279a12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0014UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]45Current NDC, Legacy NDC, 2 package rows20250515_155c7ec0-5862-404f-b1d0-f278f8a8bbda.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 050608
application number: NDA050608
ndc (product): 0049-0014
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 050608
application number: NDA050608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin / sulbactam 3 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595Unasyn 1.5 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600Unasyn 3 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595ampicillin 1000 MG / sulbactam 500 MG Injection [Unasyn]SBD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600ampicillin 2000 MG / sulbactam 1000 MG Injection [Unasyn]SBD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595Unasyn (ampicillin / sulbactam) 1.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600Unasyn (ampicillin / sulbactam) 3 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0014-81000490014811 in 1 VIALHistorical
0049-0014-830004900148310 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81) 10 vial1991-11-220000-00-00NoNoCurrent