Atropine Sulfate
- Product NDC
- 0641-6274
- 11-digit product format
- 006416274
- Labeler code
- 0641
- Product ID
- 0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVASCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA217345
- Marketing category
- ANDA
- Marketing start
- 2025-11-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atropine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190795, 1666781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6274-01 | Atropine Sulfate | 1 mL in 1 VIAL | INJECTION | 1 | | 4 |
| 0641-6274-25 | Atropine Sulfate | 25 in 1 CARTON | INJECTION | 25 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6274-01 | 00641627401 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 0641-6274-25 | 00641627425 | 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01) | 25 vial | 2025-11-07 | No | No | Historical |