Nafcillin

Product NDC: 67850-032
11-digit product format: 678500032
Labeler code: 67850
Product ID: 67850-032_b6678852-7186-4357-afd8-03fd07fb8b6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nafcillin Injection
Dosage form: POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS
Labeler: Methapharm Inc.
Application: ANDA090560
Marketing category: ANDA
Marketing start: 2019-03-05
Marketing end: 0000-00-00
Substance: NAFCILLIN SODIUM
Active strength: 2 g/2g
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

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	67850-032		D	Discontinued by firm		2026-08-17
excluded package	package	67850-032	67850-032-10	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090560-001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-10-03
A090560-002	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090560-001	AP
A090560-002	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 3 · 84 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	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090560-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090560-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-10-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A090560-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090560-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090560-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090560-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090560-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090560-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090560-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090560-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090560-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090560-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090560-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090560-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090560-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090560-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090560-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090560-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090560-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090560-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090560-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090560-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090560-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090560-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090560-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090560-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090560-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090560-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090560-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090560-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090560-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090560-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090560-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090560-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090560-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090560-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090560-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090560-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090560-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090560-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090560-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090560-002	AP	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67850-032-10	2026-01-29	C162847	48780-1	49896155-c286-586f-e063-e6dba90add90	4376871a-91c7-4730-b58d-62a2b6915de5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67850-032-10	EA - Each	67850-032	2fb0b193-5270-417a-a0a2-0d313545aa8f	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67850-032	NAFCILLIN (NAFCILLIN INJECTION) POWDER, FOR SOLUTION [METHAPHARM INC.]	8	Legacy NDC	20241207_4376871a-91c7-4730-b58d-62a2b6915de5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nafcillin	NAFCILLIN SODIUM	Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.	8a00624c-c436-4102-a042-dab54022bcc2	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090560 application number: ANDA090560
Nafcillin	NAFCILLIN	WG Critical Care, LLC	4d3b0076-3780-413f-9052-b23be5f18f01	2023-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090560 application number: ANDA090560

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67850-032-10	67850003210	10 VIAL in 1 CARTON (67850-032-10) > 2 g in 1 VIAL	10 vial	2019-03-05	0000-00-00	No	No	Current