Prescription drug · ANDA
Atropine (atropine sulfate) NDC 50090-7313
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7313-0 | 50090731300 | 1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 14, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214752
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 50090-7313_db93edb4-792e-4925-9002-90978afa8cb1SPL ID db93edb4-792e-4925-9002-90978afa8cb1SPL set ID b4736dbc-b7c8-4b33-b7a8-a47c5654a127RxCUI 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
N450090731300followed by a unit qualifier and the quantityPackage 50090-7313-00. 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.
Other NDCs under ANDA 214752
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 |
|---|---|---|---|---|
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1748 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1749 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1750 |