Oxacillin

Product NDC
70655-099
11-digit product format
706550099
Labeler code
70655
Product ID
70655-099_49fafce3-7142-43a7-9b68-ced39d296f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxacillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Renaissance SSA, LLC
Application
ANDA206681
Marketing category
ANDA
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
OXACILLIN SODIUM
Active strength
1 g/g
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct70655-099DDiscontinued by firm2026-08-11
excluded packagepackage70655-09970655-099-95DDiscontinued 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 · 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 packagepackage70655-099-95d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70655-099-95f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70655-099-952ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70655-099-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70655-099-95cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70655-099-95cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70655-099-95302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70655-099-95ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70655-099-950efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70655-099-95ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70655-099-95367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70655-099-95557ba5c1ecfa…9c80585c8c6e…

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
A206681-001OXACILLIN SODIUMOXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11
A206681-002OXACILLIN SODIUMOXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11

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 UTC2026-02A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2017-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206681-001OXACILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A206681-002OXACILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2017-09-11782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206681-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206681-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206681-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206681-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206681-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206681-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206681-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206681-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206681-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206681-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206681-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206681-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206681-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206681-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A206681-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206681-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206681-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206681-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206681-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206681-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206681-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A206681-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A206681-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206681-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206681-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206681-002AP1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206681-001AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206681-002AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70655-099-85EA - Each70655-09918abdad4-8788-4554-ab67-00afc5a9512d12018-07-03
70655-099-95EA - Each70655-0998fcda8bf-c2b2-4ee3-8ac1-520d55f3c98d12018-07-03