Atropine Sulfate
- Product NDC
- 0409-9630
- 11-digit product format
- 004099630
- Labeler code
- 0409
- Product ID
- 0409-9630_3f33c683-46fb-40db-af0d-9211bc29d2a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- NDA021146
- Marketing category
- NDA
- Marketing start
- 2004-12-31
- Substance
- ATROPINE SULFATE
- Active strength
- .05 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 | .05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190546, 1190551, 1190552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-9630-05 | Atropine Sulfate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 31 |
| 0409-9630-05 | Atropine Sulfate | 10 in 1 PACKAGE | INJECTION, SOLUTION | 10 | | 31 |
| 0409-9630-15 | Atropine Sulfate | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATROPINE SULFATE | ACTIVE INGREDIENT | 03J5ZE7KA5 | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| ATROPINE | ACTIVE MOIETY | 7C0697DR9I | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-9630 | ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] | 27 | Current NDC, Legacy NDC, 3 package rows | 20250124_ad8916e7-206e-409e-2582-30d072845dd4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-9630-05 | 00409963005 | 10 CARTON in 1 PACKAGE (0409-9630-05) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-9630-15) | 10 carton | 2004-12-31 | 0000-00-00 | No | No | Current |
| 0409-9630-15 | 00409963015 | 5 mL in 1 SYRINGE, PLASTIC | 5 ml | | | | | Historical |