Atropine Sulfate

Product NDC: 0409-4910
Requested package NDC: 0409-4910-34
11-digit product format: 004094910
Labeler code: 0409
Product ID: 0409-4910_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: 2005-08-25
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0409-4910	0409-4910-34	D	Discontinued by firm		2026-08-07

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 · 1 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 package	package	0409-4910	0409-4910-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09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 · 140 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021146-001	AP	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7480e90b-004b-ebe4-2243-4f2fefdd9e78	Product name	2	20260128
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
3f158398-73f2-4b90-47d1-5c60e8719a98	Product name	9	20250721
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0	Product name	2	20250117
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
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89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-4910-11	Atropine Sulfate	5 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	5	31
0409-4910-34	Atropine Sulfate	10 in 1 PACKAGE	INJECTION, SOLUTION	10	31
0409-4910-34	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
0409-4910-11	ML - Milliliter	0409-4910	7b5e99cd-591d-4ac6-9d42-17208892e0a1	1	2019-08-06
0409-4910-34	ML - Milliliter	0409-4910	6f6db159-a625-416c-a441-a51831573efe	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.]	3
Atropine	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	3
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	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
0409-4910	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 (package): 0409-4910-34 ndc (product): 0409-4910 ndc11 (package): 00409491034
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
1190552	atropine sulfate 0.5 MG in 5 ML Prefilled Syringe	PSN	73de9878-a08a-4966-e053-2a91aa0ab0f6	7
1190552	5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	73de9878-a08a-4966-e053-2a91aa0ab0f6	7
1190552	atropine sulfate 0.5 MG per 5 ML Prefilled Syringe	SY	73de9878-a08a-4966-e053-2a91aa0ab0f6	7
1190552	atropine sulfate 500 MCG per 5 ML Prefilled Syringe	SY	73de9878-a08a-4966-e053-2a91aa0ab0f6	7
313782	acetaminophen 325 MG Oral Tablet	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123072	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
212033	aspirin 325 MG Oral Tablet	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1190552	atropine sulfate 0.5 MG in 5 ML Prefilled Syringe	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1190546	atropine sulfate 1 MG in 10 ML Prefilled Syringe	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1795514	dextrose 50 % in 50 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1660014	EPINEPHrine 1 MG in 1 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
727373	EPINEPHrine 1 MG in 10 ML Prefilled Syringe	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
797544	isopropyl alcohol 70 % Medicated Pad	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1737761	lidocaine HCl 2 % in 5 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1012068	lidocaine HCl 2 % in 5 ML Prefilled Syringe	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
745752	ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807632	sodium chloride 0.9 % in 100 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807639	sodium chloride 0.9 % in 1000 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807627	sodium chloride 0.9 % in 150 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807630	sodium chloride 0.9 % in 25 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807633	sodium chloride 0.9 % in 250 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807631	sodium chloride 0.9 % in 50 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807634	sodium chloride 0.9 % in 500 ML Injection	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
859088	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
801095	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
859088	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
801095	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
745752	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]	SBD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1660014	1 ML epinephrine 1 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1190546	10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
727373	10 ML epinephrine 0.1 MG/ML Prefilled Syringe	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807632	100 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807639	1000 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807627	150 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807630	25 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807633	250 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1190552	5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1012068	5 ML lidocaine hydrochloride 20 MG/ML Prefilled Syringe	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1795514	50 ML glucose 500 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807631	50 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807634	500 ML sodium chloride 9 MG/ML Injection	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
313782	acetaminophen 325 MG Oral Tablet	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
212033	aspirin 325 MG Oral Tablet	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123076	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
801092	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
2123072	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807632	100 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807639	1000 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807627	150 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
745752	200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807630	25 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807633	250 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
727517	50 ML dextrose 50 % Prefilled Syringe	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807631	50 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
1807634	500 ML NaCl 9 MG/ML Injection	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3
801092	albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler	SY	9ef8edbd-047a-40fe-a603-d71fce8ada68	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-4910-34	00409491034	10 CARTON in 1 PACKAGE (0409-4910-34) > 1 SYRINGE, GLASS in 1 CARTON > 5 mL in 1 SYRINGE, GLASS (0409-4910-11)	10 carton	2005-08-25	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.	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	4
ATROPINE SULFATE INJECTION, USP 0.5mg (0.1 mg/mL) SYR, 5mL	HF Acquisition Co., LLC, DBA Health First \| HF Acquisition Co. LLC, DBA Health First	2024-01-25	HUMAN PRESCRIPTION DRUG LABEL	7
Atropine Sulfate	General Injectables & Vaccines, Inc.	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	9
Model AA-8565CV-ACT Model AA-8565CV	Aerospace Accessory Service, Inc	2021-05-18	MEDICAL DEVICE	3
Sodium Chloride	Aerospace Accessory Service, Inc	2021-05-18	MEDICAL DEVICE	3
ATROPINE SULFATE	Hospira, Inc.	2020-04-03	HUMAN PRESCRIPTION DRUG LABEL	9