Prescription drug · ANDA
Atropine Sulfate NDC 51662-1619
Atropine sulfate .4 mg/mL · Injection · Endotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1619-1 | 51662161901 | 20 mL in 1 VIAL (51662-1619-1)Marketed from Nov 10, 2022 | |
| 51662-1619-3 | 51662161903 | 10 POUCH in 1 CASE (51662-1619-3) / 1 VIAL in 1 POUCH (51662-1619-2) / 20 mL in 1 VIALMarketed from Oct 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Endotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213561
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 51662-1619_100d196c-c853-3cf7-e063-6294a90ad8c2SPL ID 100d196c-c853-3cf7-e063-6294a90ad8c2SPL set ID e9fd624a-9abd-dfea-e053-2a95a90a8e9dRxCUI 1190776UNII 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
N451662161901followed by a unit qualifier and the quantityPackage 51662-1619-01. 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 is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213561
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 .4 mg/mL | InjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4329 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | InjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6251 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | InjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7316 |