Atropine Sulfate
- Product NDC
- 84549-001
- 11-digit product format
- 845490001
- Labeler code
- 84549
- Product ID
- 84549-001_3ef1a1a0-93c2-e6b6-e063-6294a90aa2b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA216120
- Marketing category
- ANDA
- Marketing start
- 2022-08-02
- Substance
- ATROPINE SULFATE
- Active strength
- 1 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190795 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-001-25 | Atropine Sulfate | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-001-25 | 84549000125 | 1 mL in 1 VIAL, GLASS (84549-001-25) | 1 ml | 2025-09-17 | No | No | Current |