Atropine Sulfate
- Product NDC
- 70518-4188
- 11-digit product format
- 705184188
- Labeler code
- 70518
- Product ID
- 70518-4188_3ff282ac-a0db-a6e8-e063-6394a90ac8b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- REMEDYREPACK INC.
- Application
- NDA209260
- Marketing category
- NDA
- Marketing start
- 2024-09-26
- Substance
- ATROPINE SULFATE
- Active strength
- .4 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 | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190776 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4188-0 | Atropine Sulfate | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 4 |
| 70518-4188-1 | Atropine Sulfate | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4188 | ATROPINE SULFATE INJECTION, SOLUTION [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20241213_532aa441-92ec-42d6-862a-639f8cfe9951.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 |
|---|
| 70518-4188-0 | 70518418800 | 10 VIAL, MULTI-DOSE in 1 TRAY (70518-4188-0) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4188-1) | | 2024-09-26 | No | No | Historical |
| 70518-4188-1 | 70518418801 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | | | | Historical |