Atropine Sulfate
- Product NDC
- 70069-716
- 11-digit product format
- 700690716
- Labeler code
- 70069
- Product ID
- 70069-716_07ece291-b401-4c28-9c81-6b686aa36e07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate Monohydrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA217791
- Marketing category
- ANDA
- Marketing start
- 2024-05-24
- 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 |
|---|
| 70069-716-01 | Atropine Sulfate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 70069-716-01 | Atropine Sulfate | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-716 | ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE) SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 4 | Current NDC, 2 package rows | 20240526_bfdb85b2-86d0-4f32-a8fa-272af48a191c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-716-01 | 70069071601 | 1 BOTTLE in 1 CARTON (70069-716-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-05-24 | No | No | Current |