Atropine Sulfate

Product NDC: 70518-4329
11-digit product format: 705184329
Labeler code: 70518
Product ID: 70518-4329_402f9b6a-ab10-09d9-e063-6394a90a3edf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atropine Sulfate
Dosage form: INJECTION
Route: ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: REMEDYREPACK INC.
Application: ANDA213561
Marketing category: ANDA
Marketing start: 2025-04-15
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
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…`

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
8663ff94-8bea-4061-9fd5-3ab2e85e862e	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
70518-4329-0	Atropine Sulfate	10 in 1 CARTON	INJECTION	10		2
70518-4329-1	Atropine Sulfate	20 mL in 1 VIAL	INJECTION	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4329	ATROPINE SULFATE INJECTION [REMEDYREPACK INC.]	1	Current NDC, 2 package rows	20250418_8663ff94-8bea-4061-9fd5-3ab2e85e862e.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	REMEDYREPACK INC.	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561 ndc (product): 70518-4329
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

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	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2
1190776	atropine sulfate 0.4 MG/ML Injectable Solution	SCD	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2
1190776	atropine sulfate 1 MG per 2.5 ML Injectable Solution	SY	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2
1190776	atropine sulfate 1.2 MG per 3 ML Injectable Solution	SY	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2
1190776	atropine sulfate 2 MG per 5 ML Injectable Solution	SY	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2
1190776	atropine sulfate 8 MG per 20 ML Injectable Solution	SY	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4329-0	70518432900	10 VIAL in 1 CARTON (70518-4329-0) / 20 mL in 1 VIAL (70518-4329-1)	10 vial	2025-04-15	No	No	Current
70518-4329-1	70518432901	20 mL in 1 VIAL	20 ml				Historical