Isopto Atropine

Product NDC: 0065-0303
11-digit product format: 000650303
Labeler code: 0065
Product ID: 0065-0303_b3493429-e973-4c38-8e7b-23376075bd20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atropine sulfate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA208151
Marketing category: NDA
Marketing start: 2018-08-01
Substance: ATROPINE SULFATE
Active strength: 10 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

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	0065-0303	0065-0303-55	D	Discontinued by firm		2026-08-07

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 · 12 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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208151-001	ISOPTO ATROPINE	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208151-001	AT2

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2016-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC			2016-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC			2016-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC			2016-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC			2016-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208151-001	ISOPTO ATROPINE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-12-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208151-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208151-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208151-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208151-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208151-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208151-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208151-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208151-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208151-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208151-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208151-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208151-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208151-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208151-001	AT2	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208151-001	AT2	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATROPINE SULFATE	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190655	Internal RxNorm lookup
1190664	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
20491566-e6eb-8d4a-3083-77ea429f7bc4	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
0065-0303-55	Isopto Atropine	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		8
0065-0303-55	Isopto Atropine	1 in 1 CARTON	SOLUTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0303-55	ML - Milliliter	0065-0303	001e5b82-f791-44b4-a501-27528e60e889	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0303	ISOPTO ATROPINE (ATROPINE SULFATE) SOLUTION [ALCON LABORATORIES, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20221012_20491566-e6eb-8d4a-3083-77ea429f7bc4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atropine sulfate	ATROPINE SULFATE	Alcon Laboratories, Inc.	c8093125-ed1a-4eb6-9c81-52c5c7376481	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208151 application number: NDA208151
Isopto Atropine	ATROPINE SULFATE	Alcon Laboratories, Inc.	20491566-e6eb-8d4a-3083-77ea429f7bc4	2022-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208151 application number: NDA208151 ndc (product): 0065-0303

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
1190655	atropine sulfate 1 % Ophthalmic Solution	PSN	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190664	Isopto Atropine 1 % Ophthalmic Solution	PSN	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190664	atropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine]	SBD	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190655	atropine sulfate 10 MG/ML Ophthalmic Solution	SCD	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190655	atropine sulfate 1 % Ophthalmic Solution	SY	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190664	Isopto Atropine 1 % Ophthalmic Solution	SY	20491566-e6eb-8d4a-3083-77ea429f7bc4	8
1190664	Isopto Atropine 10 MG/ML Ophthalmic Solution	SY	20491566-e6eb-8d4a-3083-77ea429f7bc4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0303-15	00065030315	1 BOTTLE, DROPPER in 1 CARTON (0065-0303-15) > 15 mL in 1 BOTTLE, DROPPER	2016-12-09	0000-00-00	No	No	Current
0065-0303-55	00065030355	1 BOTTLE, DROPPER in 1 CARTON (0065-0303-55) > 5 mL in 1 BOTTLE, DROPPER	2016-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isopto Atropine	Alcon Laboratories, Inc. \| Boehringer Ingelheim Pharma GmbH & Co. KG	2022-10-07	HUMAN PRESCRIPTION DRUG LABEL	8