Atropine Sulfate

Product NDC: 0409-4911
11-digit product format: 004094911
Labeler code: 0409
Product ID: 0409-4911_77d2cecb-001f-4b7b-b8ee-94c8b6d89be5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATROPINE SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA021146
Marketing category: NDA
Marketing start: 2005-10-25
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: 2022-12-31
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	0409-4911		D	Discontinued by firm		2026-08-17
excluded package	package	0409-4911	0409-4911-34	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0409-4911		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-4911	0409-4911-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021146-001	ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09
N021146-002	ATROPINE SULFATE	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09
N021146-003	ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021146-001	AP
N021146-002	AP
N021146-003	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 4 · 143 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 106 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	N021146-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021146-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021146-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021146-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-001	AP	1	`1e350fbaab3a…`

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-4911-11	Atropine Sulfate	10 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	10	31
0409-4911-34	Atropine Sulfate	10 in 1 PACKAGE	INJECTION, SOLUTION	10	31
0409-4911-34	Atropine Sulfate	1 in 1 CARTON	INJECTION, SOLUTION	1	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-4911-11	ML - Milliliter	0409-4911	10ed536d-53eb-4928-bb93-ec3e0d9634ff	1	2019-08-06
0409-4911-34	ML - Milliliter	0409-4911	d865d899-26ee-422a-b9e8-2019843ecf33	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	11
Atropine Sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Atropine	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [CARDINAL HEALTH]	1
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [CARDINAL HEALTH]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ATROPINE SULFATE INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ATROPINE SULFATE INJECTION, SOLUTION [CARDINAL HEALTH]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-4911	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	27	Legacy NDC, 3 package rows	20250124_ad8916e7-206e-409e-2582-30d072845dd4.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	768dc21a-b7d9-144c-e053-2991aa0af889	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146
Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	ad8916e7-206e-409e-2582-30d072845dd4	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (product): 0409-4911
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	d4839e54-b350-4643-8e6e-f0437f5349d6	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	66710a22-2eaa-6dbd-e053-2a91aa0a900d	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146

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
1190551	atropine sulfate 0.25 MG in 5 ML Prefilled Syringe	PSN	ad8916e7-206e-409e-2582-30d072845dd4	31
1190552	atropine sulfate 0.5 MG in 5 ML Prefilled Syringe	PSN	ad8916e7-206e-409e-2582-30d072845dd4	31
1190546	atropine sulfate 1 MG in 10 ML Prefilled Syringe	PSN	ad8916e7-206e-409e-2582-30d072845dd4	31
1190546	10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	ad8916e7-206e-409e-2582-30d072845dd4	31
1190551	5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe	SCD	ad8916e7-206e-409e-2582-30d072845dd4	31
1190552	5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	ad8916e7-206e-409e-2582-30d072845dd4	31
1190551	atropine sulfate 0.25 MG per 5 ML Prefilled Syringe	SY	ad8916e7-206e-409e-2582-30d072845dd4	31
1190552	atropine sulfate 0.5 MG per 5 ML Prefilled Syringe	SY	ad8916e7-206e-409e-2582-30d072845dd4	31
1190546	atropine sulfate 1 MG per 10 ML Prefilled Syringe	SY	ad8916e7-206e-409e-2582-30d072845dd4	31
1190552	atropine sulfate 500 MCG per 5 ML Prefilled Syringe	SY	ad8916e7-206e-409e-2582-30d072845dd4	31
1190546	atropine sulfate 1 MG in 10 ML Prefilled Syringe	PSN	74106ef7-83bf-47ba-e053-2991aa0aaec1	10
1190546	10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	74106ef7-83bf-47ba-e053-2991aa0aaec1	10
1190546	atropine sulfate 1 MG per 10 ML Prefilled Syringe	SY	74106ef7-83bf-47ba-e053-2991aa0aaec1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-4911-11	00409491111	10 mL in 1 SYRINGE, GLASS	10 ml					Historical
0409-4911-34	00409491134	10 CARTON in 1 PACKAGE (0409-4911-34) > 1 SYRINGE, GLASS in 1 CARTON > 10 mL in 1 SYRINGE, GLASS (0409-4911-11)	10 carton	2005-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atropine Sulfate	Hospira, Inc.	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	31
Atropine Sulfate	Henry Schein, Inc.	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	6
ATROPINE SULFATE INJECTION, USP 1mg (0.1mg/mL) SYR, 10mL	HF Acquisition Co. LLC, DBA Health First	2024-03-08	HUMAN PRESCRIPTION DRUG LABEL	10
Atropine Sulfate	General Injectables & Vaccines, Inc	2022-12-08	HUMAN PRESCRIPTION DRUG LABEL	13
ATROPINE SULFATE	Hospira, Inc.	2020-04-03	HUMAN PRESCRIPTION DRUG LABEL	9
ATROPINE SULFATE	REMEDYREPACK INC.	2020-03-27	HUMAN PRESCRIPTION DRUG LABEL	2
ATROPINE SULFATE	Cardinal Health	2019-09-13	HUMAN PRESCRIPTION DRUG LABEL	3
ATROPINE SULFATE	A-S Medication Solutions	2018-01-09	HUMAN PRESCRIPTION DRUG LABEL	3