OXACILLIN

Product NDC: 0338-1015
11-digit product format: 003381015
Labeler code: 0338
Product ID: 0338-1015_dc761dcc-7333-4b1c-90be-e9ec96e7b2aa
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: 2026-12-31
Current FDA listing: Yes

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	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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
127e7924-fd95-4662-8461-0d47883074e5	Product name	3	20210203
ddeeaac2-48c2-8216-8ed2-9c12f504c245	Product name	6	20210203
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
980e9fdc-5dbe-4457-ab38-34447ecf5aef	Product name	1	20150323
044bb259-bf89-755b-5d75-d23b61ed145b	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1015-41	ML - Milliliter	0338-1015	df8be042-31fc-4afb-8082-17adcc54d51e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXACILLIN SODIUM	ACTIVE INGREDIENT	G0V6C994Q5	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
OXACILLIN	ACTIVE MOIETY	UH95VD7V76	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXACILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050640 application number: NDA050640 ndc (product): 0338-1015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G0V6C994Q5	OXACILLIN SODIUM	7240-38-2	OXACILLIN SODIUM
UH95VD7V76	OXACILLIN	66-79-5	OXACILLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312128	oxacillin 1 GM in 50 ML Injection	PSN	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19
240637	oxacillin 2 GM in 50 ML Injection	PSN	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19
312128	50 ML oxacillin 20 MG/ML Injection	SCD	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19
240637	50 ML oxacillin 40 MG/ML Injection	SCD	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19
312128	oxacillin 1 GM per 50 ML Injection	SY	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19
240637	oxacillin 2 GM per 50 ML Injection	SY	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	19

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxacillin Injection, USP in Plastic Container For Intravenous Use Only GALAXY Container	Baxter Healthcare Corporation	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	20