Prescription drug · ANDA
Atropine Sulfate NDC 0641-6274
Atropine sulfate .4 mg/mL · Injection · Intravascular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6274-25 | 00641627425 | 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01)Marketed from Nov 7, 2025 |
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
- Route
- Intravascular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217345
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886SPL ID 4298dd9c-15f7-4bab-be40-c0250eb01886SPL set ID a66eecf9-2d8b-4e2d-8a05-d718dcbc3542RxCUI 1190795, 1666781UNII 03J5ZE7KA5UPC 0306416275255
- 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.
- NDC on a medical claim
N400641627425followed by a unit qualifier and the quantityPackage 00641-6274-25. 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
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 ANDA 217345
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 | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6275 |