Prescription drug · ANDA
Atropine Sulfate NDC 0517-1004
Atropine sulfate .4 mg/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-1004-25 | 00517100425 | 25 VIAL, GLASS in 1 TRAY (0517-1004-25) / 1 mL in 1 VIAL, GLASS (0517-1004-01)Marketed from Aug 2, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Atropine Sulfate
- Generic name (nonproprietary)
- atropine sulfate
- Active ingredients
- Atropine sulfate — .4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- American Regent, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216120
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0517-1004_1c500ed9-94a9-472c-bfb7-50e1fcfc31fbSPL ID 1c500ed9-94a9-472c-bfb7-50e1fcfc31fbSPL set ID 6fee1727-52b7-4f73-ab45-ef47d6a1c5bbRxCUI 1190795, 1666781UNII 03J5ZE7KA5UPC 0305171004254, 0305171001253
- Pharmacologic class
- Anticholinergic; Cholinergic Muscarinic Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400517100425followed by a unit qualifier and the quantityPackage 00517-1004-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 216120
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atropine Sulfate | Atropine sulfate 1 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-1001 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc | 0404-9802 |
| Atropine Sulfate | Atropine sulfate 1 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-001 |
| Atropine Sulfate | Atropine sulfate 1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1626 |
| Atropine sulfate | Atropine sulfate .4 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1627 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7312 |