Atropine Sulfate

Product NDC: 0517-0401
11-digit product format: 005170401
Labeler code: 0517
Product ID: 0517-0401_61f56e4b-78b0-4cff-8bf9-34903d828a14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atropine Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: American Regent, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1992-11-01
Marketing end: 0000-00-00
Substance: ATROPINE SULFATE
Active strength: 0 mg/mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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	0517-0401		D	Discontinued by firm		2026-08-17
excluded package	package	0517-0401	0517-0401-25	D	Discontinued by firm		2026-08-17

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 · 24 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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`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	0517-0401-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0401-25	ML - Milliliter	0517-0401	22b968d0-d806-4104-93fc-fc6b49bd4dd8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atropine Sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
Atropine	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666781	atropine sulfate 0.4 MG in 1 ML Injection	PSN	7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f0	4
1666781	1 ML atropine sulfate 0.4 MG/ML Injection	SCD	7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f0	4
1666781	atropine sulfate 0.4 MG per 1 ML Injection	SY	7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-0401-25	00517040125	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0401-25) > 1 mL in 1 VIAL, SINGLE-DOSE	1992-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATROPINE SULFATE INJECTION, USP	American Regent, Inc.	2023-08-24	HUMAN PRESCRIPTION DRUG LABEL	8
ATROPINE SULFATE INJECTION, USP	Medical Purchasing Solutions, LLC	2023-06-05	HUMAN PRESCRIPTION DRUG LABEL	4
Atropine Sulfate 0.4 mg/mL Injection, USP 1 mL Single Dose Vial	Henry Schein, Inc.	2022-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Atropine Sulfate 0.4 mg/mL Injection, USP 1 mL Single Dose Vial	General Injectables & Vaccines, Inc	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	5
ATROPINE SULFATE INJECTION, USP 0.4mg/mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4