Atropine Sulfate

Product NDC: 0404-9804
Requested package NDC: 0404-9804-20
11-digit product format: 004049804
Labeler code: 0404
Product ID: 0404-9804_f146f48d-bd05-46f2-ad39-b930a05ea158
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atropine Sulfate
Dosage form: INJECTION, SOLUTION
Route: ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: NDA209260
Marketing category: NDA
Marketing start: 2024-10-01
Substance: ATROPINE SULFATE
Active strength: .4 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209260-001	ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209260-001	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 · 42 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	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL		RLD, RS	2018-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209260-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	RLD, RS	2018-01-26	`e64feba35796…`

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	N209260-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209260-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209260-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209260-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209260-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209260-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209260-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209260-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209260-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209260-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209260-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209260-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209260-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209260-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209260-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209260-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209260-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209260-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209260-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209260-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209260-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209260-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209260-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209260-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209260-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209260-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209260-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209260-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209260-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209260-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209260-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209260-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209260-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209260-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209260-001	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	.4 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
1190776	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
6acb3f07-9e32-4ad0-8336-e2f33d55b127	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
0404-9804-20	Atropine Sulfate	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20		2
0404-9804-20	Atropine Sulfate	1 in 1 BAG	INJECTION, SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9804	ATROPINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	1	Current NDC, 2 package rows	20241009_6acb3f07-9e32-4ad0-8336-e2f33d55b127.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	ProPharma Distribution	38404931-980b-0019-e063-6394a90a933f	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209260 application number: NDA209260
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209260 application number: NDA209260 ndc (package): 0404-9804-20 ndc (product): 0404-9804 ndc11 (package): 00404980420
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	532aa441-92ec-42d6-862a-639f8cfe9951	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209260 application number: NDA209260
Atropine Sulfate	ATROPINE SULFATE	Fresenius Kabi USA, LLC	310c8a74-ea24-4357-8099-81e394b1634e	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209260 application number: NDA209260

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
1190776	atropine sulfate 0.4 MG/ML Injectable Solution	PSN	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2
1190776	atropine sulfate 0.4 MG/ML Injectable Solution	SCD	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2
1190776	atropine sulfate 1 MG per 2.5 ML Injectable Solution	SY	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2
1190776	atropine sulfate 1.2 MG per 3 ML Injectable Solution	SY	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2
1190776	atropine sulfate 2 MG per 5 ML Injectable Solution	SY	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2
1190776	atropine sulfate 8 MG per 20 ML Injectable Solution	SY	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0404-9804-20	00404980420	1 VIAL, MULTI-DOSE in 1 BAG (0404-9804-20) / 20 mL in 1 VIAL, MULTI-DOSE	2024-10-01	No	No	Current