Atropine Sulfate
- Product NDC
- 0517-1001
- 11-digit product format
- 005171001
- Labeler code
- 0517
- Product ID
- 0517-1001_1c500ed9-94a9-472c-bfb7-50e1fcfc31fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- 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, 1666781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-1001-01 | Atropine Sulfate | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | | 8 |
| 0517-1001-25 | Atropine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-1001 | ATROPINE SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20220911_6fee1727-52b7-4f73-ab45-ef47d6a1c5bb.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 |
|---|
| 0517-1001-01 | 00517100101 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | | Historical |
| 0517-1001-25 | 00517100125 | 25 VIAL, GLASS in 1 TRAY (0517-1001-25) / 1 mL in 1 VIAL, GLASS (0517-1001-01) | | 2022-08-02 | 0000-00-00 | No | No | Current |