Home NDC 0338-1013 OXACILLIN
Product NDC 0338-1013
11-digit product format 003381013
Labeler code 0338
Product ID 0338-1013_836d4aea-dae6-470c-bb9b-640f77613e23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXACILLIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA050640
Marketing category NDA
Marketing start 1989-10-26
Marketing end 0000-00-00
Substance OXACILLIN SODIUM
Active strength 1 g/50mL
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 · 18 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0338-1013-41 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0338-1013-41 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0338-1013-41 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0338-1013-41 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0338-1013-41 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0338-1013-41 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0338-1013-41 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0338-1013-41 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0338-1013-41 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050640-001 BACTOCILL IN PLASTIC CONTAINER OXACILLIN SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 N050640-002 BACTOCILL IN PLASTIC CONTAINER OXACILLIN SODIUM EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 782e0a99824c…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-1013-41 OXACILLIN 50 mL in 1 BAG INJECTION, SOLUTION 50 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-1013 OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Legacy NDC, 1 package rows 20250502_d893e45b-7f18-4c67-b10c-1e2e52a6b3ef.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 · 1 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 0338-1013-41 00338101341 50 mL in 1 BAG (0338-1013-41) 50 ml 1989-10-26 0000-00-00 No No Current