Prescription drug · ANDA
Atropine sulfate NDC 42799-826
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-826-01 | 42799082601 | 1 BOTTLE in 1 CARTON (42799-826-01) / 2 mL in 1 BOTTLEMarketed from May 6, 2026 | |
| 42799-826-02 | 42799082602 | 1 BOTTLE in 1 CARTON (42799-826-02) / 5 mL in 1 BOTTLEMarketed from May 6, 2026 | |
| 42799-826-03 | 42799082603 | 1 BOTTLE in 1 CARTON (42799-826-03) / 15 mL in 1 BOTTLEMarketed from May 6, 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 sulfate
- Generic name (nonproprietary)
- atropine sulfate
- Active ingredients
- Atropine sulfate — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219013
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 42799-826_0e312e98-b1a3-4746-b074-b0cd28aba14eSPL ID 0e312e98-b1a3-4746-b074-b0cd28aba14eSPL set ID b39f5876-5d6f-4a8f-bd24-bd4be24ff568RxCUI 1190655UNII 03J5ZE7KA5UPC 0342799826035, 0342799826028, 0342799826011
- 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
N442799082601followed by a unit qualifier and the quantityPackage 42799-0826-01. 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: Atropine is an anticholinergic 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 ) 1.1 Cycloplegia . 1.2 Mydriasis . 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia .
Excerpt only. Read the full label for complete information.