Prescription drug · ANDA
Atropine (Atropine sulfate) NDC 60505-6226
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-6226-0 | 6050562260060505622600 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPERMarketed from Nov 26, 2021 | |
| 60505-6226-1 | 6050562260160505622601 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 26, 2021 | |
| 60505-6226-2 | 6050562260260505622602 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-2) / 15 mL in 1 BOTTLE, DROPPERMarketed from Feb 7, 2022 |
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
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215624
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 60505-6226_b7f34028-c9e4-4505-1395-1e65fd56e27fSPL ID b7f34028-c9e4-4505-1395-1e65fd56e27fSPL set ID 127a7e32-a150-01d6-a66a-b7708d85809fRxCUI 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
N460505622600followed by a unit qualifier and the quantityPackage 60505-6226-00. 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)
1. INDICATIONS AND USAGE Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: Atropine is an anticholinergic agent 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.
About NDC 60505-6226
- What is NDC 60505-6226?
- 60505-6226 is the product NDC for Atropine (atropine sulfate), Atropine sulfate 10 mg/mL solution/ drops, listed with the FDA by Apotex Corp.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atropine (Atropine Sulfate).
- What is the active ingredient?
- Atropine sulfate.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. 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?
- 9 other product NDCs are listed under this name. See all Atropine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atropine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-669 | 68083-0669-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-670 | 68083-0670-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-671 | 68083-0671-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7313 | 50090-7313-00 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1748 | 60219-1748-02 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1749 | 60219-1749-03 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1750 | 60219-1750-08 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7000 | 50090-7000-00 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2200 | 67296-2200-05 |
Other NDCs under ANDA 215624
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 | A-S Medication Solutions | 50090-7000 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2200 |