Prescription drug · NDA
Atropine Sulfate NDC 0404-9823
Atropine sulfate .05 mg/mL · Injection, Solution · Endotracheal, Intramuscular, Intravenous, Subcutaneous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9823-05 | 00404982305 | 1 SYRINGE, PLASTIC in 1 BAG (0404-9823-05) / 5 mL in 1 SYRINGE, PLASTICMarketed from Jan 9, 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 — .05 mg/mL
- Dosage form
- Injection, Solution
- Route
- Endotracheal, Intramuscular, Intravenous, Subcutaneous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021146
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0404-9823_5c087e28-0b1f-4ab1-b883-673d5d871d60SPL ID 5c087e28-0b1f-4ab1-b883-673d5d871d60SPL set ID d4839e54-b350-4643-8e6e-f0437f5349d6RxCUI 1190551UNII 03J5ZE7KA5
- 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
N400404982305followed by a unit qualifier and the quantityPackage 00404-9823-05. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Atropine Sulfate Injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life-threatening muscarinic effects. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021146
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 | Hospira, Inc. | 0409-1630 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | Injection, SolutionEndotracheal, Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1289 |
| Atropine Sulfate | Atropine sulfate .05 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-9630 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | Injection, SolutionEndotracheal, Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7002 |