Prescription drug · ANDA
Atropine (atropine sulfate) NDC 68083-670
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-670-01 | 68083067001 | 1 BOTTLE, DROPPER in 1 CARTON (68083-670-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jul 31, 2026 |
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
- Generic name (nonproprietary)
- atropine sulfate
- Active ingredients
- Atropine sulfate — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219996
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 68083-670_01f9b403-5ef9-4364-9138-7e7f65248bdeSPL ID 01f9b403-5ef9-4364-9138-7e7f65248bdeSPL set ID a116af5c-ba4c-408c-9a02-4bc33772aa8dRxCUI 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
N468083067001followed by a unit qualifier and the quantityPackage 68083-0670-01. 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 in adults and pediatric patients aged three (3) months and older for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Atropine is an anti-cholinergic indicated in adults and pediatric patients aged three (3) months and older for: • Cycloplegia (1.1) • Mydriasis (1.2) • Penalization of the healthy eye in the treatment of amblyopia (1.3)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219996
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.