Nafcillin

Product NDC: 70860-119
11-digit product format: 708600119
Labeler code: 70860
Product ID: 70860-119_2cc9cc61-54ac-9a94-e063-6394a90a2376
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nafcillin sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA090005
Marketing category: ANDA
Marketing start: 2018-08-15
Marketing end: 2026-06-30
Substance: NAFCILLIN SODIUM
Active strength: 10 g/100mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70860-119		D	Discontinued by firm		2026-08-17
excluded package	package	70860-119	70860-119-99	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090005-001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090005-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090005-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090005-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090005-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090005-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090005-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090005-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090005-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090005-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090005-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090005-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090005-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090005-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090005-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090005-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090005-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090005-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090005-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090005-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090005-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090005-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090005-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090005-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090005-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090005-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090005-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090005-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090005-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090005-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090005-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090005-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090005-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090005-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090005-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090005-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090005-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090005-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090005-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090005-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090005-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090005-001	AP	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b7b0726e-639a-4536-8d6a-d050fc34e9d8	Product name	2	20200528
f189d2f2-ff03-d646-79ae-649b7a3d8e3f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-119-99	2024-03-04	C162847	48780-1	1030e365-3ef6-111a-e063-dadaa90a10e2	Nafcillin for Injection, USP
70860-119-99	2024-01-30	C162847	48780-1	1030e365-3ef6-111a-e063-dadaa90a10e2	Nafcillin for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70860-119-99	Nafcillin	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		4
70860-119-99	Nafcillin	100 mL in 1 BOTTLE	INJECTION, POWDER, FOR SOLUTION	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-119-99	EA - Each	70860-119	638d59fd-9070-41be-8a60-a214b7db0468	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-119	NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	4	Current NDC, Legacy NDC, 2 package rows	20250130_2bc91eeb-5d8d-4058-b16a-532ba114fcd5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nafcillin	NAFCILLIN	WG Critical Care, LLC	77999cd2-17b8-4df9-b687-d0f9b62096b9	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN SODIUM	Sagent Pharmaceuticals	a6a4e122-b7f5-4eb5-8555-7aea6eda794b	2025-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN SODIUM	Avenacy Inc.	0556378a-b794-4235-ba09-ebdc295e9092	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN	NorthStar Rx, LLC	91ebf84a-310f-4271-8446-5a10a877883a	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a	2019-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
239189	nafcillin 100 MG/ML Injectable Solution	PSN	2bc91eeb-5d8d-4058-b16a-532ba114fcd5	4
239189	nafcillin 100 MG/ML Injectable Solution	SCD	2bc91eeb-5d8d-4058-b16a-532ba114fcd5	4
239189	nafcillin (as nafcillin sodium) 100 MG/ML Injectable Solution	SY	2bc91eeb-5d8d-4058-b16a-532ba114fcd5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-119-99	70860011999	1 BOTTLE in 1 CARTON (70860-119-99) / 100 mL in 1 BOTTLE	1 bottle	2018-08-15	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nafcillin for Injection, USP	Athenex Pharmaceutical Division, LLC.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	4