ATROPINE SULFATE

Product NDC: 51662-1626
Requested package NDC: 51662-1626-3
11-digit product format: 516621626
Labeler code: 51662
Product ID: 51662-1626_100be173-227f-a802-e063-6294a90ae92e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATROPINE SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA216120
Marketing category: ANDA
Marketing start: 2023-07-13
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
A216120-001	ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26
A216120-002	ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216120-001	AP
A216120-002	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 · 60 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	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A216120-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216120-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216120-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216120-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216120-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216120-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216120-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216120-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216120-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216120-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216120-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216120-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216120-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	AP	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A216120-001	CGT	2023-01-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	CGT	2023-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	CGT	2023-01-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	CGT	2023-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216120-001	CGT	2023-01-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216120-002	CGT	2023-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216120-001	CGT	2023-01-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216120-002	CGT	2023-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216120-001	CGT	2023-01-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216120-002	CGT	2023-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216120-001	CGT	2023-01-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216120-002	CGT	2023-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216120-001	CGT	2023-01-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216120-002	CGT	2023-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216120-001	CGT	2023-01-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216120-002	CGT	2023-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216120-001	CGT	2023-01-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A216120-002	CGT	2023-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216120-001	CGT	2023-01-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A216120-002	CGT	2023-01-29	`e64feba35796…`

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
0060b971-19bd-2849-e063-6294a90afca8	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1626-1	ATROPINE SULFATE	1 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	1	4
51662-1626-2	ATROPINE SULFATE	1 in 1 POUCH	INJECTION, SOLUTION	1	4
51662-1626-3	ATROPINE SULFATE	25 in 1 CASE	INJECTION, SOLUTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1626	ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, 3 package rows	20240130_0060b971-19bd-2849-e063-6294a90afca8.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 · 6 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	b753894e-81f8-4e81-b07a-c338311ded5b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3ef1a1a0-93c1-e6b6-e063-6294a90aa2b6	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	0060b971-19bd-2849-e063-6294a90afca8	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120 ndc (package): 51662-1626-3 ndc (product): 51662-1626 ndc11 (package): 51662162603
Atropine sulfate	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	007728fc-f4cb-d519-e063-6394a90ae033	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	09d086f2-db9a-5e15-e063-6394a90abe18	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	6fee1727-52b7-4f73-ab45-ef47d6a1c5bb	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120

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	0060b971-19bd-2849-e063-6294a90afca8	4
1190795	1 ML atropine sulfate 1 MG/ML Injection	SCD	0060b971-19bd-2849-e063-6294a90afca8	4
1190795	atropine sulfate 1 MG per 1 ML Injection	SY	0060b971-19bd-2849-e063-6294a90afca8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51662-1626-3	51662162603	25 POUCH in 1 CASE (51662-1626-3) / 1 VIAL, GLASS in 1 POUCH (51662-1626-2) / 1 mL in 1 VIAL, GLASS (51662-1626-1)	25 pouch	2023-10-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATROPINE SULFATE INJECTION, USP 1mg/mL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	4