Atropine Sulfate
- Product NDC
- 0409-1630
- 11-digit product format
- 004091630
- Labeler code
- 0409
- Product ID
- 0409-1630_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
- 2006-01-19
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-1630-10 | Atropine Sulfate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 0409-1630-10 | Atropine Sulfate | 10 in 1 PACKAGE | INJECTION, SOLUTION | 10 | 31 | |
| 0409-1630-15 | Atropine Sulfate | 10 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 10 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1630-10 | ML - Milliliter | 0409-1630 | 72853dbf-3fea-4d8b-bdff-177506372a54 | 1 | 2012-07-24 |
| 0409-1630-15 | ML - Milliliter | 0409-1630 | 8664a6a5-ebf2-4871-8910-4bbc0b925b9d | 1 | 2019-12-10 |
DailyMed Socrata Ingredients#
| 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#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190551 | atropine sulfate 0.25 MG in 5 ML Prefilled Syringe | PSN | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190552 | atropine sulfate 0.5 MG in 5 ML Prefilled Syringe | PSN | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190551 | 5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe | SCD | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190552 | 5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190551 | atropine sulfate 0.25 MG per 5 ML Prefilled Syringe | SY | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190552 | atropine sulfate 0.5 MG per 5 ML Prefilled Syringe | SY | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190552 | atropine sulfate 500 MCG per 5 ML Prefilled Syringe | SY | ad8916e7-206e-409e-2582-30d072845dd4 | 31 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 768dc21a-b7d9-144c-e053-2991aa0af889 | 10 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 768dc21a-b7d9-144c-e053-2991aa0af889 | 10 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | 768dc21a-b7d9-144c-e053-2991aa0af889 | 10 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 66710a22-2eaa-6dbd-e053-2a91aa0a900d | 4 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 66710a22-2eaa-6dbd-e053-2a91aa0a900d | 4 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | 66710a22-2eaa-6dbd-e053-2a91aa0a900d | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-1630-10 | 00409163010 | 10 CARTON in 1 PACKAGE (0409-1630-10) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1630-15) | 10 carton | 2006-01-19 | 0000-00-00 | No | No | Current |
| 0409-1630-15 | 00409163015 | 10 mL in 1 SYRINGE, PLASTIC | 10 ml | Historical |