oxacillin

Product NDC
83270-307
11-digit product format
832700307
Labeler code
83270
Product ID
83270-307_4972ec74-1d9b-de9b-e063-6394a90af786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxacillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Onesource Specialty Pharma Limited
Application
ANDA091486
Marketing category
ANDA
Marketing start
2022-09-21
Substance
OXACILLIN SODIUM
Active strength
2 g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091486-001OXACILLIN SODIUMOXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25
A091486-002OXACILLIN SODIUMOXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091486-002AP

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2014-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091486-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2014-08-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A091486-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2014-08-25782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091486-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091486-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091486-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091486-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091486-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091486-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091486-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091486-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091486-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091486-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091486-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091486-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091486-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091486-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091486-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091486-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091486-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091486-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091486-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091486-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091486-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091486-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091486-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091486-002AP13a93d1ddd44b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091486-002AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXACILLIN SODIUM2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G0V6C994Q5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743547Internal RxNorm lookup
1743549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4972ec74-1d9a-de9b-e063-6394a90af786Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
127e7924-fd95-4662-8461-0d47883074e5Product name320210203
ddeeaac2-48c2-8216-8ed2-9c12f504c245Product name620210203
980e9fdc-5dbe-4457-ab38-34447ecf5aefProduct name120150323
044bb259-bf89-755b-5d75-d23b61ed145bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83270-307-10oxacillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
83270-307-10oxacillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

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
oxacillinOXACILLINOnesource Specialty Pharma Limited4972ec74-1d9a-de9b-e063-6394a90af7862025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091486
application number: ANDA091486
ndc (product): 83270-307
OxacillinOXACILLINArmas Pharmaceuticals Inc.8e99d6fe-42ab-44c1-8b51-e4ac7406dbe42025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091486
application number: ANDA091486

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743547oxacillin 1 GM InjectionPSN4972ec74-1d9a-de9b-e063-6394a90af7861
1743549oxacillin 2 GM InjectionPSN4972ec74-1d9a-de9b-e063-6394a90af7861
1743547oxacillin 1000 MG InjectionSCD4972ec74-1d9a-de9b-e063-6394a90af7861
1743549oxacillin 2000 MG InjectionSCD4972ec74-1d9a-de9b-e063-6394a90af7861
1743547oxacillin (as oxacillin sodium) 1000 MG InjectionSY4972ec74-1d9a-de9b-e063-6394a90af7861
1743549oxacillin (as oxacillin sodium) 2000 MG InjectionSY4972ec74-1d9a-de9b-e063-6394a90af7861
1743547oxacillin 1 GM InjectionSY4972ec74-1d9a-de9b-e063-6394a90af7861
1743549oxacillin 2 GM InjectionSY4972ec74-1d9a-de9b-e063-6394a90af7861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-307-108327003071010 VIAL in 1 CARTON (83270-307-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2022-09-21NoNoCurrent