UNASYN

Product NDC
0049-0023
11-digit product format
000490023
Labeler code
0049
Product ID
0049-0023_d137a407-16ac-4b7b-8646-db443e3e565a
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
Marketing end
0000-00-00
Substance
AMPICILLIN SODI
Active strength
2 g/1; g/1
Pharmacologic classes
Penicillin-clas
NDC exclude flag
No
Listing certified through
2019-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0049-0023DDiscontinued by firm2026-08-10
excluded packagepackage0049-00230049-0023-83DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0049-0023-83d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0049-0023-83f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0049-0023-832ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0049-0023-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0049-0023-83cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0049-0023-83cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0049-0023-83302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0049-0023-83ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0049-0023-830efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0049-0023-83ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0049-0023-83367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0049-0023-83557ba5c1ecfa…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-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…

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
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 050608
application number: NDA050608