Atropine Sulfate

Product NDC: 71872-7245
Requested package NDC: 71872-7245-1
11-digit product format: 718727245
Labeler code: 71872
Product ID: 71872-7245_eaef17bc-bf14-6157-e053-2a95a90a3910
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATROPINE SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: NDA214652
Marketing category: NDA
Marketing start: 2021-01-11
Substance: ATROPINE SULFATE
Active strength: 1 mg/mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	71872-7245	71872-7245-1	E	Excluded after deficient or non-compliant submission was not corrected		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
N214652-001	ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29
N214652-002	ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N214652-001	AP
N214652-002	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 2 · 76 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	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 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	N214652-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214652-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214652-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214652-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214652-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214652-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214652-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214652-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214652-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214652-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214652-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214652-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214652-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214652-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214652-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214652-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214652-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214652-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214652-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214652-002	AP	1	`9b2671bbb829…`

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	Strength	SPL version
71872-7245-1	Atropine Sulfate	1 in 1 BAG	INJECTION, SOLUTION	1		2
71872-7245-1	Atropine Sulfate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71872-7245	ATROPINE SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20221014_bfc8a727-0cb8-3152-e053-2995a90a28ba.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	4a9559e8-7a34-4509-a8cc-ff0125694539	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214652 application number: NDA214652

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
1190795	atropine sulfate 1 MG in 1 ML Injection	PSN	bfc8a727-0cb8-3152-e053-2995a90a28ba	2
1190795	1 ML atropine sulfate 1 MG/ML Injection	SCD	bfc8a727-0cb8-3152-e053-2995a90a28ba	2
1190795	atropine sulfate 1 MG per 1 ML Injection	SY	bfc8a727-0cb8-3152-e053-2995a90a28ba	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71872-7245-1	71872724501	1 VIAL, SINGLE-DOSE in 1 BAG (71872-7245-1) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-03-30	0000-00-00	No	No	Current