Atropine
- Product NDC
- 50090-6295
- 11-digit product format
- 500906295
- Labeler code
- 50090
- Product ID
- 50090-6295_932ff92f-a5c2-4766-be9e-6196e6b40d4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- NDA206289
- Marketing category
- NDA
- Marketing start
- 2022-05-02
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-6295-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43a7-111a-e063-dadaa90a10e2 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-6295-0 | Atropine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 1 | |
| 50090-6295-0 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6295-0 | ML - Milliliter | 50090-6295 | 77ede557-96bc-405d-8924-08ed878701ad | 1 | 2023-02-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6295 | ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20221229_57760bfa-38bc-48cb-a898-96a55e0072d2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190655 | atropine sulfate 1 % Ophthalmic Solution | PSN | 57760bfa-38bc-48cb-a898-96a55e0072d2 | 1 |
| 1190655 | atropine sulfate 10 MG/ML Ophthalmic Solution | SCD | 57760bfa-38bc-48cb-a898-96a55e0072d2 | 1 |
| 1190655 | atropine sulfate 1 % Ophthalmic Solution | SY | 57760bfa-38bc-48cb-a898-96a55e0072d2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-6295-0 | 50090629500 | 1 BOTTLE, DROPPER in 1 CARTON (50090-6295-0) > 5 mL in 1 BOTTLE, DROPPER | 2022-12-23 | 0000-00-00 | No | No | Current |