Atropine Sulfate

Product NDC: 71872-7340
Requested package NDC: 71872-7340-1
11-digit product format: 718727340
Labeler code: 71872
Product ID: 71872-7340_3f931184-42aa-22f3-e063-6294a90ade79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atropine Sulfate
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA215969
Marketing category: ANDA
Marketing start: 2024-07-04
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

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
A215969-001	ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-07-03
A215969-002	ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215969-001	AP
A215969-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215969-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215969-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-07-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215969-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215969-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215969-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215969-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215969-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215969-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215969-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215969-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215969-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215969-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215969-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215969-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215969-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215969-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215969-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215969-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215969-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215969-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215969-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215969-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215969-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215969-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215969-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215969-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215969-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215969-002	AP	1	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215969-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215969-002	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atropine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATROPINE SULFATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
03J5ZE7KA5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190795	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f931937-7bc0-416b-e063-6294a90a28b5	Available on FDA.report

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
71872-7340-1	Atropine Sulfate	1 mL in 1 VIAL	SOLUTION	1		1
71872-7340-1	Atropine Sulfate	1 in 1 BAG	SOLUTION	1		1

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	Medical Purchasing Solutions, LLC	3fa81939-4495-28d5-e063-6394a90a1f2d	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215969 application number: ANDA215969
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3eef6300-9c78-82b2-e063-6294a90a5499	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215969 application number: ANDA215969
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	3f931937-7bc0-416b-e063-6294a90a28b5	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215969 application number: ANDA215969 ndc (package): 71872-7340-1 ndc (product): 71872-7340 ndc11 (package): 71872734001
Atropine Sulfate	ATROPINE SULFATE	Somerset Therapeutics, LLC	a6fac578-c7bc-4b3c-a454-7889cc819118	2024-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215969 application number: ANDA215969

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	3f931937-7bc0-416b-e063-6294a90a28b5	1
1190795	1 ML atropine sulfate 1 MG/ML Injection	SCD	3f931937-7bc0-416b-e063-6294a90a28b5	1
1190795	atropine sulfate 1 MG per 1 ML Injection	SY	3f931937-7bc0-416b-e063-6294a90a28b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71872-7340-1	71872734001	1 VIAL in 1 BAG (71872-7340-1) / 1 mL in 1 VIAL	1 vial	2025-01-03	No	No	Current