Oxacillin

Product NDC
0781-3101
11-digit product format
007813101
Labeler code
0781
Product ID
0781-3101_85b9177b-c221-461a-8de8-60d3569bd0b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxacillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA061490
Marketing category
ANDA
Marketing start
1976-01-06
Marketing end
0000-00-00
Substance
OXACILLIN SODIUM
Active strength
2 g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
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 productproduct0781-3101DDiscontinued by firm2026-08-11
excluded packagepackage0781-31010781-3101-95DDiscontinued by firm2026-08-11

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-3101-95DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-3101-95DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-3101-95DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-3101-95DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-3101-95DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-3101-95DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-3101-95DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-3101-95DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-3101-95DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-3101-95DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-3101-95DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-3101-95DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0781-3101-95IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0781-3101-95IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061490-001OXACILLIN SODIUMOXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982
A061490-002OXACILLIN SODIUMOXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982
A061490-003OXACILLIN SODIUMOXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982
A061490-004OXACILLIN SODIUMOXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982
A061490-006OXACILLIN SODIUMOXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-09

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061490-001OXACILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061490-002OXACILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061490-003OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061490-004OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061490-006OXACILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1991-05-095bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3101-952021-02-26C16284748780-19d75b9d0-d1d1-f424-e053-dadaa90a57ceOxacillin for Injection, USP
0781-3101-952020-01-31C16284748780-19d75b9d0-d1d1-f424-e053-dadaa90a57ceOxacillin for Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3101-80EA - Each0781-31010ca29655-4994-4cf8-93db-db8fe6bc7dbf12012-07-24
0781-3101-95EA - Each0781-31012634c288-c770-44ea-b6ac-89d0dac058ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXACILLIN SODIUMACTIVE INGREDIENTG0V6C994Q5OXACILLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14
OXACILLINACTIVE MOIETYUH95VD7V76OXACILLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74OXACILLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14