Home NDC 82449-506 oxacillin
Product NDC 82449-506
11-digit product format 824490506
Labeler code 82449
Product ID 82449-506_e9b9ffe1-7b66-7c1f-e053-2a95a90a45cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxacillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Steriscience Specialties Private Limited
Application ANDA091486
Marketing category ANDA
Marketing start 2022-09-21
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 82449-506-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 82449-506-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 82449-506-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 82449-506-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 82449-506-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 82449-506-02 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091486-001 OXACILLIN SODIUM OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 A091486-002 OXACILLIN SODIUM OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091486-002 AP
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 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091486-001 OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091486-002 OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-08-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82449-506 OXACILLIN INJECTION, POWDER, FOR SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED] 7 Legacy NDC 20241205_a835cc3a-c5f6-40b6-bb86-6009b1a56e9e.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82449-506-02 82449050602 10 VIAL in 1 CARTON (82449-506-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2022-09-19 0000-00-00 No No Current