Prescription drug · ANDA
Atropine Sulfate (atropine sulfate injection) NDC 84549-400
Atropine sulfate .1 mg/mL · Injection, Solution · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-400-91 | 84549040091 | 10 mL in 1 SYRINGE, PLASTIC (84549-400-91)Marketed from Sep 16, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 injection
- Active ingredients
- Atropine sulfate — .1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ProPharma Distribution
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214970
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 84549-400_3eeed115-0e16-c4b2-e063-6294a90a29b7SPL ID 3eeed115-0e16-c4b2-e063-6294a90a29b7SPL set ID 3eeed115-0e17-c4b2-e063-6294a90a29b7RxCUI 1190546UNII 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
N484549040091followed by a unit qualifier and the quantityPackage 84549-0400-91. 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, USP, 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. These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214970
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 Sulfateatropine sulfate injection | Atropine sulfate .1 mg/mL | Injection, SolutionIntravenous | Medefil, Inc. | 64253-400 |