Prescription drug · NDA
Atropine Sulfate NDC 24208-965
Atropine sulfate 10 mg/mL · Solution · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-965-01 | 24208096501 | 10 VIAL in 1 CARTON (24208-965-01) / .4 mL in 1 VIALMarketed from Jul 13, 2022 |
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 — 10 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb Incorporated
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213581
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 24208-965_32c411c4-f4b0-fc14-e063-6394a90a2955SPL ID 32c411c4-f4b0-fc14-e063-6394a90a2955SPL set ID aeab333c-3cdb-45c0-9e22-949624d69fbcRxCUI 1190655UNII 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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N424208096501followed by a unit qualifier and the quantityPackage 24208-0965-01. 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 Sulfate Ophthalmic Solution, USP 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 213581
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 10 mg/mL | SolutionOphthalmic | Bausch & Lomb Americas Inc. | 82260-001 |