NAFCILLIN

Product NDC: 0338-1019
11-digit product format: 003381019
Labeler code: 0338
Product ID: 0338-1019_ad3cc424-4e9f-49e8-b72b-6969ae6b16b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAFCILLIN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA050655
Marketing category: NDA
Marketing start: 1989-10-31
Substance: NAFCILLIN SODIUM
Active strength: 2 g/100mL
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
N050655-001	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION		RLD	1989-10-31
N050655-002	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	EQ 2GM BASE/100ML	INJECTABLE / INJECTION		RLD, RS	1989-10-31

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: NAFCILLIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAFCILLIN SODIUM	2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
49G3001BCK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1721458	Internal RxNorm lookup
1721460	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
cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	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
b7b0726e-639a-4536-8d6a-d050fc34e9d8	Product name	2	20200528
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
f189d2f2-ff03-d646-79ae-649b7a3d8e3f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-1019-48	NAFCILLIN	100 mL in 1 BAG	INJECTION, SOLUTION	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1019-48	ML - Milliliter	0338-1019	16077108-56fb-4801-bd89-35c1f1a0d4a8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAFCILLIN SODIUM	ACTIVE INGREDIENT	49G3001BCK	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
NAFCILLIN	ACTIVE MOIETY	4CNZ27M7RV	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1019	NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	19	Current NDC, Legacy NDC, 1 package rows	20250502_cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416.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
NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050655 application number: NDA050655 ndc (product): 0338-1019

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
49G3001BCK	NAFCILLIN SODIUM	7177-50-6	NAFCILLIN SODIUM
4CNZ27M7RV	NAFCILLIN	147-52-4	NAFCILLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1721458	nafcillin 1 GM Injection	PSN	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721460	nafcillin 2 GM Injection	PSN	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721458	nafcillin 1000 MG Injection	SCD	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721460	nafcillin 2000 MG Injection	SCD	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721458	nafcillin (as nafcillin sodium) 1 GM Injection	SY	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721460	nafcillin (as nafcillin sodium) 2 GM Injection	SY	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721458	nafcillin 1 GM Injection	SY	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19
1721460	nafcillin 2 GM Injection	SY	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1019-48	00338101948	100 mL in 1 BAG (0338-1019-48)	100 ml	1989-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nafcillin Injection, USP in Plastic Container For Intravenous Use Only GALAXY Container	Baxter Healthcare Corporation	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	20