Atropine
- Product NDC
- 76478-015
- 11-digit product format
- 764780015
- Labeler code
- 76478
- Product ID
- 76478-015_afc6513a-0654-4cf7-8391-ef90f1ec44db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 76478-015-02 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1d1e-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 |
| 76478-015-05 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1d1e-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 |
| 76478-015-15 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1d1e-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 |
| 76478-015-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d1e-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 |
| 76478-015-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d1e-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 |
| 76478-015-15 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d1e-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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76478-015-02 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 76478-015-02 | Atropine | 2 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2 | | 4 |
| 76478-015-05 | Atropine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 4 |
| 76478-015-05 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 76478-015-15 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 76478-015-15 | Atropine | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76478-015 | ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN] | 4 | Legacy NDC, 6 package rows | 20230118_6818d479-860a-422e-be16-6589392b063f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76478-015-02 | 76478001502 | 1 BOTTLE, DROPPER in 1 CARTON (76478-015-02) > 2 mL in 1 BOTTLE, DROPPER | 2022-05-02 | 0000-00-00 | No | No | Current |
| 76478-015-05 | 76478001505 | 1 BOTTLE, DROPPER in 1 CARTON (76478-015-05) > 5 mL in 1 BOTTLE, DROPPER | 2022-05-02 | 0000-00-00 | No | No | Current |
| 76478-015-15 | 76478001515 | 1 BOTTLE, DROPPER in 1 CARTON (76478-015-15) > 15 mL in 1 BOTTLE, DROPPER | 2022-05-02 | 0000-00-00 | No | No | Current |