atropine sulfate 10 MG/ML Ophthalmic Solution
- RxCUI
- 1190655
- RxNorm name
- atropine sulfate 10 MG/ML Ophthalmic Solution
- Display name
- Atropine (Ophthalmic)
- Full name
- atropine sulfate 10 MG/ML Ophthalmic Solution
- Term type
- SCD
- Status
- Active
- Strength
- 1%
- Dose form
- Sol
- Route
- Ophthalmic
- Updated
- 2026-08-03 17:32:51
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 112011
- Active start
- 112011
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| atropine sulfate | 10 MG / 1 ML | atropine | atropine sulfate |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Ophthalmic Solution | 7670 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| atropine | 1223 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | atropine sulfate 10 MG/ML Ophthalmic Solution | 1 | NAMES |
| RxNorm Name | atropine sulfate 10 MG/ML Ophthalmic Solution | 1 | NAMES |
| RxNorm Synonym | atropine sulfate 1 % Ophthalmic Solution | 1 | NAMES |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 14 linked values
| 14 | CODES |
| RxCUI | 1190655 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0065-0817-01 | 0065-0817 | atropine sulfate atropine sulfate | Alcon Laboratories, Inc. | NDA208151 |
| 0065-0817-02 | 0065-0817 | atropine sulfate atropine sulfate | Alcon Laboratories, Inc. | NDA208151 |
| 24208-965-01 | 24208-965 | Atropine Sulfate Atropine Sulfate | Bausch & Lomb Incorporated | NDA213581 |
| 42799-826-01 | 42799-826 | Atropine sulfate Atropine sulfate | Edenbridge Pharmaceuticals LLC. | ANDA219013 |
| 42799-826-02 | 42799-826 | Atropine sulfate Atropine sulfate | Edenbridge Pharmaceuticals LLC. | ANDA219013 |
| 42799-826-03 | 42799-826 | Atropine sulfate Atropine sulfate | Edenbridge Pharmaceuticals LLC. | ANDA219013 |
| 50090-7000-0 | 50090-7000 | Atropine Atropine Sulfate | A-S Medication Solutions | ANDA215624 |
| 50090-7313-0 | 50090-7313 | ATROPINE atropine sulfate | A-S Medication Solutions | ANDA214752 |
| 60219-1748-2 | 60219-1748 | Atropine Atropine Sulfate | Amneal Pharmaceuticals NY LLC | ANDA214752 |
| 60219-1749-3 | 60219-1749 | Atropine atropine sulfate | Amneal Pharmaceuticals NY LLC | ANDA214752 |
| 60219-1750-8 | 60219-1750 | Atropine atropine sulfate | Amneal Pharmaceuticals NY LLC | ANDA214752 |
| 60505-6226-0 | 60505-6226 | Atropine Atropine Sulfate | Apotex Corp. | ANDA215624 |
| 60505-6226-1 | 60505-6226 | Atropine Atropine Sulfate | Apotex Corp. | ANDA215624 |
| 60505-6226-2 | 60505-6226 | Atropine Atropine Sulfate | Apotex Corp. | ANDA215624 |
| 67296-2124-5 | 67296-2124 | Atropine Sulfate Atropine Sulfate | Redpharm Drug | ANDA218148 |
| 67296-2200-5 | 67296-2200 | Atropine Atropine Sulfate | Redpharm Drug | ANDA215624 |
| 70069-581-01 | 70069-581 | Atropine sulfate Atropine sulfate | Somerset Therapeutics, LLC | ANDA215618 |
| 70069-582-01 | 70069-582 | Atropine sulfate Atropine sulfate | Somerset Therapeutics, LLC | ANDA215618 |
| 70069-583-01 | 70069-583 | Atropine sulfate Atropine sulfate | Somerset Therapeutics, LLC | ANDA215618 |
| 70069-716-01 | 70069-716 | Atropine Sulfate Atropine Sulfate Monohydrate | Somerset Therapeutics, LLC | ANDA217791 |
| 70756-651-25 | 70756-651 | Atropine Sulfate Atropine Sulfate | Lifestar Pharma LLC | ANDA218148 |
| 70756-652-25 | 70756-652 | Atropine Sulfate Atropine Sulfate | Lifestar Pharma LLC | ANDA218148 |
| 70756-653-35 | 70756-653 | Atropine Sulfate Atropine Sulfate | Lifestar Pharma LLC | ANDA218148 |
| 72603-264-01 | 72603-264 | Atropine Sulfate Atropine Sulfate | NorthStar RxLLC | ANDA218148 |
| 72603-264-02 | 72603-264 | Atropine Sulfate Atropine Sulfate | NorthStar RxLLC | ANDA218148 |
| 82260-001-01 | 82260-001 | Atropine Sulfate Atropine Sulfate | Bausch & Lomb Americas Inc. | NDA213581 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| NDA208151 | 0065-0817 | atropine sulfate atropine sulfate | NDA | Alcon Laboratories, Inc. |
| NDA213581 | 24208-965 | Atropine Sulfate Atropine Sulfate | NDA | Bausch & Lomb Incorporated |
| ANDA219013 | 42799-826 | Atropine sulfate Atropine sulfate | ANDA | Edenbridge Pharmaceuticals LLC. |
| ANDA215624 | 50090-7000 | Atropine Atropine Sulfate | ANDA | A-S Medication Solutions |
| ANDA214752 | 50090-7313 | ATROPINE atropine sulfate | ANDA | A-S Medication Solutions |
| ANDA218148 | 67296-2124 | Atropine Sulfate Atropine Sulfate | ANDA | Redpharm Drug |
| ANDA215618 | 70069-581 | Atropine sulfate Atropine sulfate | ANDA | Somerset Therapeutics, LLC |
| ANDA217791 | 70069-716 | Atropine Sulfate Atropine Sulfate Monohydrate | ANDA | Somerset Therapeutics, LLC |
UNII Substances#
No records found.
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.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 12 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | 20220701 |
| f8718be5-8fa4-4c36-a4fd-fac7c3953f5a | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 10 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. A TROPINE SULFATE ophthalmic solution , 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20251204 |
| c8093125-ed1a-4eb6-9c81-52c5c7376481 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 8 | ATROPINE SULFATE - atropine sulfate solution These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval 1960 | 20260313 |
| 127a7e32-a150-01d6-a66a-b7708d85809f | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 8 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, 1% for topical ophthalmic use. Initial U.S. Approval: 1960 | 20260310 |
| e30491ed-938e-4ef4-aa23-a2e94cbab0ed | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 8 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval:1960 | 20250529 |
| 20491566-e6eb-8d4a-3083-77ea429f7bc4 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 8 | These highlights do not include all the information needed to use ISOPTO® ATROPINE safely and effectively. See full prescribing information for ISOPTO® ATROPINE ISOPTO® ATROPINE (atropine sulfate ophthalmic solution) 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20221007 |
| aeab333c-3cdb-45c0-9e22-949624d69fbc | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 5 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20250414 |
| e294ce2b-6bb5-4f84-8a6d-ce2402ed926d | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20260207 |
| 301ea0f4-a1dc-ad4f-e063-6294a90acc1c | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | 20251223 |
| b5f78b2a-56d1-4400-9d2f-b033cc13d26e | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20251013 |
| bfdb85b2-86d0-4f32-a8fa-272af48a191c | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION ATROPINE SULFATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1960 | 20240524 |
| 6818d479-860a-422e-be16-6589392b063f | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | 20220701 |
| 590a4e7b-565f-415f-a8e4-499a382c9a3b | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 4 | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | 20220430 |
| b4736dbc-b7c8-4b33-b7a8-a47c5654a127 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 3 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. A TROPINE SULFATE ophthalmic solution , 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20260210 |
| f750135c-e6bf-4aa7-a343-87b1204df94f | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 3 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | 20251112 |
| b39f5876-5d6f-4a8f-bd24-bd4be24ff568 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 2 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use. Initial U.S. Approval: 1960 | 20260507 |
| 46e98d0b-3a04-7feb-e063-6394a90ac75e | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 1 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, 1% for topical ophthalmic use. Initial U.S. Approval: 1960 | 20251227 |
| 1b2d030e-c0ec-484b-a228-76011702cdd0 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 1 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, for topical application to the eye. Initial U.S. Approval: 1960 | 20240102 |
| 57760bfa-38bc-48cb-a898-96a55e0072d2 | atropine sulfate 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [SCD] · atropine sulfate 1 % Ophthalmic Solution [SY] | 3 | 1 | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | 20221227 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| b39f5876-5d6f-4a8f-bd24-bd4be24ff568 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use. Initial U.S. Approval: 1960 | Edenbridge Pharmaceuticals LLC. | 20260507 |
| b39f5876-5d6f-4a8f-bd24-bd4be24ff568 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use. Initial U.S. Approval: 1960 | Edenbridge Pharmaceuticals LLC. | 20260422 |
| c8093125-ed1a-4eb6-9c81-52c5c7376481 | ATROPINE SULFATE - atropine sulfate solution These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval 1960 | Alcon Laboratories, Inc. | Boehringer Ingelheim Pharma GmbH & Co. KG | Laurus Labs Limited | Alcon Research LLC | 20260313 |
| 127a7e32-a150-01d6-a66a-b7708d85809f | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, 1% for topical ophthalmic use. Initial U.S. Approval: 1960 | Apotex Corp. | Apotex Inc. | 20260310 |
| b4736dbc-b7c8-4b33-b7a8-a47c5654a127 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. A TROPINE SULFATE ophthalmic solution , 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | A-S Medication Solutions | 20260210 |
| e294ce2b-6bb5-4f84-8a6d-ce2402ed926d | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | Bausch & Lomb Americas Inc. | Unither Manufacturing LLC | 20260207 |
| 46e98d0b-3a04-7feb-e063-6394a90ac75e | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, 1% for topical ophthalmic use. Initial U.S. Approval: 1960 | Redpharm Drug | 20251227 |
| 301ea0f4-a1dc-ad4f-e063-6294a90acc1c | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | Redpharm Drug | 20251223 |
| f8718be5-8fa4-4c36-a4fd-fac7c3953f5a | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. A TROPINE SULFATE ophthalmic solution , 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | 20251204 |
| f750135c-e6bf-4aa7-a343-87b1204df94f | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | NorthStar RxLLC | Mankind Pharma Limited | 20251112 |
| b5f78b2a-56d1-4400-9d2f-b033cc13d26e | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | Lifestar Pharma LLC | Mankind Pharma Limited | 20251013 |
| e30491ed-938e-4ef4-aa23-a2e94cbab0ed | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval:1960 | Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | 20250529 |
| aeab333c-3cdb-45c0-9e22-949624d69fbc | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%, for topical ophthalmic use Initial U.S. Approval: 1960 | Bausch & Lomb Incorporated | Unither Manufacturing LLC | 20250414 |
| f750135c-e6bf-4aa7-a343-87b1204df94f | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | NorthStar RxLLC | Mankind Pharma Limited | 20240626 |
| bfdb85b2-86d0-4f32-a8fa-272af48a191c | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION ATROPINE SULFATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1960 | Somerset Therapeutics, LLC | Somerset Therapeutics Limited | 20240524 |
| b5f78b2a-56d1-4400-9d2f-b033cc13d26e | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | Lifestar Pharma LLC | Mankind Pharma Limited | 20240111 |
| 1b2d030e-c0ec-484b-a228-76011702cdd0 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE Ophthalmic Solution, for topical application to the eye. Initial U.S. Approval: 1960 | A-S Medication Solutions | 20240102 |
| 41100cf2-143b-4a1b-a8b9-867a99f3d7f7 | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | A-S Medication Solutions | 20230206 |
| 57760bfa-38bc-48cb-a898-96a55e0072d2 | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | A-S Medication Solutions | 20221227 |
| f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a | These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960 | Akorn | 20220701 |
| 6818d479-860a-422e-be16-6589392b063f | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | Akorn | 20220701 |
| 590a4e7b-565f-415f-a8e4-499a382c9a3b | These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%. Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye. Initial U.S. Approval: 1960 | MWI | Akorn Operating Company LLC | Akorn | 20220430 |
| 468e72ca-9053-467b-83ef-714ae7fe1298 | National Council for Prescription Drug Programs | 20130213 | |
| 0f7ccc3f-1472-4636-b127-a54987f7a828 | National Council for Prescription Drug Programs | 20130213 | |
| 4c372acf-2e97-43be-a1fc-d2529f4565f1 | National Council for Prescription Drug Programs | 20130213 | |
| 70543d01-634a-418b-8796-0d134dd2cb74 | National Council for Prescription Drug Programs | 20130213 | |
| 9e8c2a9a-5f72-440a-bd75-9680e353a0f3 | National Council for Prescription Drug Programs | 20120724 | |
| 9bba8c11-12ab-43e6-b7aa-f68859925398 | National Council for Prescription Drug Programs | 20120724 | |
| 96390ac0-5727-44aa-bf30-b2f4b5727a28 | National Council for Prescription Drug Programs | 20120724 | |
| 7118e980-b2d1-4d06-aba1-84123b933f26 | National Council for Prescription Drug Programs | 20120724 | |
| 635e9bd3-8df4-48dd-85b2-4d13933b4633 | National Council for Prescription Drug Programs | 20120724 | |
| f80bc7fe-d79f-4ca5-8832-bdf383179040 | National Council for Prescription Drug Programs | 20120724 | |
| 60c25795-07d1-4ba3-bb98-b1ad5c30a58f | National Council for Prescription Drug Programs | 20120724 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | S01FA | Anticholinergics | ATC1-4 | atropine | |
| ATC | A03BA | Belladonna alkaloids, tertiary amines | ATC1-4 | atropine | |
| FDASPL | N0000175574 | Anticholinergic | EPC | has_epc | atropine |
| FDASPL | N0000175700 | Cholinergic Muscarinic Antagonist | EPC | has_epc | atropine |
| FDASPL | N0000175370 | Cholinergic Antagonists | MOA | has_moa | atropine |
| FDASPL | N0000000125 | Cholinergic Muscarinic Antagonists | MOA | has_moa | atropine |
| MEDRT | D001285 | Atropine | CHEM | has_ingredient | atropine |
| MEDRT | D001285 | Atropine | CHEM | has_ingredient | atropine sulfate |
| MEDRT | D001249 | Asthma | DISEASE | ci_with | atropine |
| MEDRT | D001249 | Asthma | DISEASE | ci_with | atropine sulfate |
| MEDRT | D001919 | Bradycardia | DISEASE | may_treat | atropine |
| MEDRT | D001919 | Bradycardia | DISEASE | may_treat | atropine sulfate |
| MEDRT | D003093 | Colitis, Ulcerative | DISEASE | ci_with | atropine |
| MEDRT | D003093 | Colitis, Ulcerative | DISEASE | ci_with | atropine sulfate |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | atropine |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | atropine sulfate |
| MEDRT | D064420 | Drug-Related Side Effects and Adverse Reactions | DISEASE | may_treat | atropine |
| MEDRT | D064420 | Drug-Related Side Effects and Adverse Reactions | DISEASE | may_treat | atropine sulfate |
| MEDRT | D015812 | Glaucoma, Angle-Closure | DISEASE | ci_with | atropine |
| MEDRT | D015812 | Glaucoma, Angle-Closure | DISEASE | ci_with | atropine sulfate |
| MEDRT | D006323 | Heart Arrest | DISEASE | may_treat | atropine |
| MEDRT | D006323 | Heart Arrest | DISEASE | may_treat | atropine sulfate |
| MEDRT | D006327 | Heart Block | DISEASE | ci_with | atropine sulfate |
| MEDRT | D006327 | Heart Block | DISEASE | ci_with | atropine |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | atropine |
| MEDRT | D007415 | Intestinal Obstruction | DISEASE | ci_with | atropine sulfate |
| MEDRT | D007499 | Iris Diseases | DISEASE | ci_with | atropine |
| MEDRT | D007499 | Iris Diseases | DISEASE | ci_with | atropine sulfate |
| MEDRT | D007674 | Kidney Diseases | DISEASE | ci_with | atropine sulfate |
| MEDRT | D007674 | Kidney Diseases | DISEASE | ci_with | atropine |
| MEDRT | D007905 | Lens Diseases | DISEASE | ci_with | atropine sulfate |
| MEDRT | D007905 | Lens Diseases | DISEASE | ci_with | atropine |
| MEDRT | D008107 | Liver Diseases | DISEASE | ci_with | atropine sulfate |
| MEDRT | D008107 | Liver Diseases | DISEASE | ci_with | atropine |
| MEDRT | D008532 | Megacolon, Toxic | DISEASE | ci_with | atropine sulfate |
| MEDRT | D008532 | Megacolon, Toxic | DISEASE | ci_with | atropine |
| MEDRT | D009157 | Myasthenia Gravis | DISEASE | ci_with | atropine sulfate |
| MEDRT | D009157 | Myasthenia Gravis | DISEASE | ci_with | atropine |
| MEDRT | D015878 | Mydriasis | DISEASE | induces | atropine |
| MEDRT | D015878 | Mydriasis | DISEASE | induces | atropine sulfate |
| MEDRT | D011041 | Poisoning | DISEASE | may_treat | atropine sulfate |
| MEDRT | D011041 | Poisoning | DISEASE | may_treat | atropine |
| MEDRT | D012848 | Sinoatrial Block | DISEASE | may_treat | atropine sulfate |
| MEDRT | D012848 | Sinoatrial Block | DISEASE | may_treat | atropine |
| MEDRT | D013276 | Stomach Ulcer | DISEASE | may_treat | atropine sulfate |
| MEDRT | D013276 | Stomach Ulcer | DISEASE | may_treat | atropine |
| MEDRT | D013610 | Tachycardia | DISEASE | ci_with | atropine sulfate |
| MEDRT | D013610 | Tachycardia | DISEASE | ci_with | atropine |
| MEDRT | D013971 | Thyrotoxicosis | DISEASE | ci_with | atropine |
| MEDRT | D013971 | Thyrotoxicosis | DISEASE | ci_with | atropine sulfate |
| MEDRT | D000267 | Tissue Adhesions | DISEASE | ci_with | atropine |
| MEDRT | D000267 | Tissue Adhesions | DISEASE | ci_with | atropine sulfate |
| MEDRT | D014517 | Ureteral Obstruction | DISEASE | ci_with | atropine |
| MEDRT | D014517 | Ureteral Obstruction | DISEASE | ci_with | atropine sulfate |
| MEDRT | D014605 | Uveitis | DISEASE | may_treat | atropine |
| MEDRT | D014605 | Uveitis | DISEASE | may_treat | atropine sulfate |
| MEDRT | D014987 | Xerostomia | DISEASE | induces | atropine sulfate |
| MEDRT | D014987 | Xerostomia | DISEASE | induces | atropine |
| MEDRT | N0000000125 | Cholinergic Muscarinic Antagonists | MOA | has_moa | atropine |
| MEDRT | N0000000125 | Cholinergic Muscarinic Antagonists | MOA | has_moa | atropine sulfate |
| MEDRT | N0000008779 | Decreased Parasympathetic Acetylcholine Activity | PE | has_pe | atropine |
| MEDRT | N0000008779 | Decreased Parasympathetic Acetylcholine Activity | PE | has_pe | atropine sulfate |
| MEDRT | N0000008868 | Decreased Respiratory Secretions | PE | has_pe | atropine |
| MEDRT | N0000008868 | Decreased Respiratory Secretions | PE | has_pe | atropine sulfate |
| MEDRT | N0000009808 | Positive Chronotropy | PE | has_pe | atropine |
| MEDRT | N0000009808 | Positive Chronotropy | PE | has_pe | atropine sulfate |
| MEDRT | N0000009820 | Pupillary Dilation | PE | has_pe | atropine |
| MEDRT | N0000009820 | Pupillary Dilation | PE | has_pe | atropine sulfate |
| MEDRT | N0000009842 | Salivation Inhibition | PE | has_pe | atropine sulfate |
| MEDRT | N0000009842 | Salivation Inhibition | PE | has_pe | atropine |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 10 MG/ML |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA214752 |
| CODES | ANDA | ANDA215618 |
| CODES | ANDA | ANDA215624 |
| CODES | ANDA | ANDA217791 |
| CODES | ANDA | ANDA218148 |
| CODES | ANDA | ANDA219013 |
| CODES | NDA | NDA208151 |
| CODES | NDA | NDA213581 |
| CODES | SNOMEDCT | 330548006 |
| CODES | VUID | 4000629 |
| CODES | VUID | 4042561 |
| NAMES | Prescribable Synonym | atropine sulfate 1 % Ophthalmic Solution |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | US Edition of SNOMED_CT |
| SOURCES | Source | Veterans Health Administration National Drug File |