Prescription drug · ANDA
Atropine Sulfate NDC 16729-483
Atropine sulfate .05 mg/mL · Injection · Intravenous · Accord Healthcare, Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-483-03 | 16729048303 | 10 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASSMarketed from Aug 19, 2021 | |
| 16729-483-31 | 16729048331 | 5 mL in 1 SYRINGE, GLASS (16729-483-31)Marketed from Jul 30, 2021 |
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
- Active ingredients
- Atropine sulfate — .05 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Accord Healthcare, Inc.,
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212868
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 16729-483_4082a1cf-1e1b-6f40-e063-6294a90aec06SPL ID 4082a1cf-1e1b-6f40-e063-6294a90aec06SPL set ID c82cb295-ffce-47d6-97ad-a8aa723f4e4fRxCUI 1190546, 1190551, 1190552UNII 03J5ZE7KA5UPC 0316729483315, 0316729484039, 0316729484312
- 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
N416729048303followed by a unit qualifier and the quantityPackage 16729-0483-03. 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 212868
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 | Accord Healthcare, Inc., | 16729-484 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7298 |