Atropine sulfate
- Product NDC
- 70069-583
- 11-digit product format
- 700690583
- Labeler code
- 70069
- Product ID
- 70069-583_43d3dd59-36b1-493f-86a3-c5eee9750ee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA215618
- Marketing category
- ANDA
- Marketing start
- 2025-02-12
- 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
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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190655 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-583-01 | Atropine sulfate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
| 70069-583-01 | Atropine sulfate | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 8 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-583-01 | 70069058301 | 1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE | 1 bottle | 2025-02-12 | No | No | Current |