Prescription drug · NDA AUTHORIZED GENERIC
Atropine Sulfate NDC 82260-001
Atropine sulfate 10 mg/mL · Solution · Ophthalmic · Bausch & Lomb Americas Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82260-001-01 | 8226000010182260000101 | 10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIALMarketed from Apr 21, 2023 |
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 Americas Inc.NDC labeler code 82260
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 213581
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 82260-001_4a46793e-5e69-1a65-e063-6294a90a6880SPL ID 4a46793e-5e69-1a65-e063-6294a90a6880SPL set ID e294ce2b-6bb5-4f84-8a6d-ce2402ed926dRxCUI 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
N482260000101followed by a unit qualifier and the quantityPackage 82260-0001-01. 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.
About NDC 82260-001
- What is NDC 82260-001?
- 82260-001 is the product NDC for Atropine Sulfate, Atropine sulfate 10 mg/mL solution, listed with the FDA by Bausch & Lomb Americas Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atropine Sulfate.
- What is the active ingredient?
- Atropine sulfate.
- Who is the labeler?
- Bausch & Lomb Americas Inc., NDC labeler code 82260. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atropine Sulfate?
- 61 other product NDCs are listed under this name. See all Atropine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atropine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Edenbridge Pharmaceuticals LLC. | 42799-826 | 42799-0826-0142799-0826-0242799-0826-03 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | InjectionIntravascular | Hikma Pharmaceuticals USA Inc. | 0641-6274 | 00641-6274-25 |
| Atropine Sulfate | Atropine sulfate 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6275 | 00641-6275-25 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9784 | 00404-9784-05 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | InjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4329 | 70518-4329-00 |
| Atropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-583 | 70069-0583-01 |
| Atropine Sulfateatropine sulfate monohydrate | Atropine sulfate .4 mg/mL | SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7355 | 71872-7355-01 |
| Atropine Sulfateatropine sulfate monohydrate | Atropine sulfate .4 mg/mL | SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC | 70069-481 | 70069-0481-10 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | 0404-9804 | 00404-9804-20 |
| Atropine Sulfate | Atropine sulfate .4 mg/mL | Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4188 | 70518-4188-00 |
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 Incorporated | 24208-965 |