Physostigmine Salicylate

Product NDC: 17478-510
11-digit product format: 174780510
Labeler code: 17478
Product ID: 17478-510_b67787ff-fa3a-4881-8279-efaca81fb111
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Physostigmine Salicylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-08-10
Marketing end: 0000-00-00
Substance: PHYSOSTIGMINE SALICYLATE
Active strength: 1 mg/mL
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	17478-510		I	Inactivated by FDA		2026-09-09
excluded package	package	17478-510	17478-510-02	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-510-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-510-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-510-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-510-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-510-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-510-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-510-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-510-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-510-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-510-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-510-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-510-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-510-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-510-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-510-02	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-510-02	2024-01-30	C162847	48780-1	1030e365-0565-111a-e063-dadaa90a10e2	Physostigmine Salicylate Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-510-02	Physostigmine Salicylate	2 mL in 1 AMPULE	INJECTION	2		6
17478-510-02	Physostigmine Salicylate	10 in 1 CARTON	INJECTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-510-02	ML - Milliliter	17478-510	45b64667-38a6-4fa6-9b0c-ca4d0718ca29	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
physostigmine salicylate	ACTIVE INGREDIENT	2046ZRO9VU	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	1
physostigmine	ACTIVE MOIETY	9U1VM840SP	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	1
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-510	PHYSOSTIGMINE SALICYLATE INJECTION [AKORN]	6	Legacy NDC, 2 package rows	20221211_a7d04b2c-fe34-480d-8f7c-7cbcf447a70b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2046ZRO9VU	PHYSOSTIGMINE SALICYLATE	57-64-7	PHYSOSTIGMINE SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
990982	PHYSostigmine salicylate 1 MG/ML in 2 ML Injection	PSN	a7d04b2c-fe34-480d-8f7c-7cbcf447a70b	6
990982	2 ML physostigmine salicylate 1 MG/ML Injection	SCD	a7d04b2c-fe34-480d-8f7c-7cbcf447a70b	6
990982	physostigmine salicylate 1 MG/ML per 2 ML Injection	SY	a7d04b2c-fe34-480d-8f7c-7cbcf447a70b	6
990982	PHYSostigmine salicylate 1 MG/ML in 2 ML Injection	PSN	9a448a78-356c-50f7-e053-2995a90adefa	3
990982	2 ML physostigmine salicylate 1 MG/ML Injection	SCD	9a448a78-356c-50f7-e053-2995a90adefa	3
990982	physostigmine salicylate 1 MG/ML per 2 ML Injection	SY	9a448a78-356c-50f7-e053-2995a90adefa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-510-02	17478051002	10 AMPULE in 1 CARTON (17478-510-02) > 2 mL in 1 AMPULE	10 ampule	2010-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHYSOSTIGMINE SALICYLATE INJECTION (1mg/mL) 2mL AMPULE	HF Acquisition Co LLC, DBA HealthFirst	2023-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
PHYSOSTIGMINE SALICYLATE INJECTION Rx only	Henry Schein, Inc.	2022-10-26	HUMAN PRESCRIPTION DRUG LABEL	2
Physostigmine Salicylate Injection	Akorn	2022-09-13	HUMAN PRESCRIPTION DRUG LABEL	6
PHYSOSTIGMINE SALICYLATE INJECTION Rx only	General Injectables and Vaccines, Inc.a	2021-11-19	HUMAN PRESCRIPTION DRUG LABEL	2
Physostigmine Salicylate Injection	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	3
Physostigmine Salicylate Injection	Medical Purchasing Solutions, LLC	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	2