ATROPINE SULFATE

Product NDC: 0404-9990
Requested package NDC: 0404-9990-20
11-digit product format: 004049990
Labeler code: 0404
Product ID: 0404-9990_5db3983a-5133-43dd-a4cd-233387616c53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atropine sulfate injection
Dosage form: INJECTION
Route: ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: ANDA213561
Marketing category: ANDA
Marketing start: 2022-12-21
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: 2023-12-31
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	0404-9990	0404-9990-20	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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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
A213561-001	ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP		2021-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213561-001	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.

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	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`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	A213561-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213561-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213561-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213561-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213561-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213561-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213561-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213561-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213561-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213561-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213561-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213561-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213561-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213561-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213561-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213561-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213561-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213561-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213561-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213561-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213561-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213561-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213561-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213561-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213561-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213561-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213561-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213561-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213561-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213561-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213561-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213561-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213561-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213561-001	AP	1	`a50c72e98297…`

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	REMEDYREPACK INC.	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fd624a-9abd-dfea-e053-2a95a90a8e9d	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	0aab13de-04bf-2a14-e063-6294a90aae11	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561
Atropine Sulfate	ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	4c15d3cc-7888-4c82-b3f8-a5d93c5523df	2023-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9990-20	00404999020	1 PACKAGE in 1 BAG (0404-9990-20) > 20 mL in 1 PACKAGE	1 package	2022-12-21	0000-00-00	No	No	Current