Home NDC 0338-1015 OXACILLIN
Product NDC 0338-1015
11-digit product format 003381015
Labeler code 0338
Product ID 0338-1015_25553ed1-2375-4bb9-96ec-13f54e0af857
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
Substance OXACILLIN SODIUM
Active strength 2 g/50mL
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 43 .
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 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 · 86 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 2026-09-14 22:38:34 2026-08 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD 1989-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050640-001 BACTOCILL IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD 1989-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050640-002 BACTOCILL IN PLASTIC CONTAINER EQ 40MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-26 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OXACILLIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXACILLIN SODIUM 2 g/50mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240637 Internal RxNorm lookup 312128 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 0338-1015-41 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 0338-1015 OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Current NDC, 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 0338-1015-41 00338101541 50 mL in 1 BAG (0338-1015-41) 50 ml 1989-10-26 0000-00-00 No No Current