Prescription drug · NDA
atropine sulfate NDC 0065-0817
Atropine sulfate 10 mg/mL · Solution · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0817-01 | 0006508170100065081701 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2022 | |
| 0065-0817-02 | 0006508170200065081702 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2022 |
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 — 10 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.NDC labeler code 0065
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208151
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0065-0817_96e742ed-f4e5-4e9c-b383-7c8b9fac1a43SPL ID 96e742ed-f4e5-4e9c-b383-7c8b9fac1a43SPL set ID c8093125-ed1a-4eb6-9c81-52c5c7376481RxCUI 1190655UNII 03J5ZE7KA5UPC 0300650817011, 0300650817028
- 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
N400065081701followed by a unit qualifier and the quantityPackage 00065-0817-01. 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, 1% is indicated for: Atropine Sulfate Ophthalmic Solution, 1% is a muscarinic antagonist 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 0065-0817
- What is NDC 0065-0817?
- 0065-0817 is the product NDC for atropine sulfate, Atropine sulfate 10 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 2 package NDCs, 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?
- Alcon Laboratories, Inc., NDC labeler code 0065. 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 208151
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 |
|---|---|---|---|---|
| Isopto Atropineatropine sulfate | Atropine sulfate 10 mg/mL | SolutionOphthalmic | Alcon Laboratories, Inc. | 0065-0303 |