Home NDC 72485-409 Oxacillin
Product NDC 72485-409
11-digit product format 724850409
Labeler code 72485
Product ID 72485-409_4530516e-55de-6b94-e063-6394a90a3e2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxacillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Armas Pharmaceuticals Inc.
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 2026-12-31
Current FDA listing Yes 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# Additional Listing Data#
Finished product Yes
Brand name base Oxacillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXACILLIN SODIUM 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G0V6C994Q5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1743549 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72485-409-01 Oxacillin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 3 72485-409-10 Oxacillin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-409 OXACILLIN INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240104_8e99d6fe-42ab-44c1-8b51-e4ac7406dbe4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72485-409-01 72485040901 1 in 1 VIAL Historical 72485-409-10 72485040910 10 VIAL in 1 CARTON (72485-409-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-409-01) 10 vial 2022-09-21 0000-00-00 No No Current