Over-the-counter drug · ANDA
Leader Olopatadine Hydrochloride Ophthalmic Solution NDC 70000-0717
olopatadine hydrochloride ophthalmic solution · Olopatadine hydrochloride 1 mg/mL · Solution · Ophthalmic · CARDINAL HEALTH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0717-1 | 7000007170170000071701 | 1 BOTTLE in 1 CARTON (70000-0717-1) / 5 mL in 1 BOTTLEMarketed from Apr 15, 2025 |
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)
- Leader Olopatadine Hydrochloride Ophthalmic Solution
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic solution
- Active ingredients
- Olopatadine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- CARDINAL HEALTHNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206046
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0717_5b76eaf7-4541-a87c-e063-6294a90a8b47SPL ID 5b76eaf7-4541-a87c-e063-6294a90a8b47
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
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
N470000071701followed by a unit qualifier and the quantityPackage 70000-0717-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70000-0717
- What is NDC 70000-0717?
- 70000-0717 is the product NDC for Leader Olopatadine Hydrochloride Ophthalmic Solution, Olopatadine hydrochloride 1 mg/mL solution, listed with the FDA by CARDINAL HEALTH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Olopatadine Hydrochloride Ophthalmic Solution (Olopatadine Hydrochloride Ophthalmic Solution).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- CARDINAL HEALTH, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader Olopatadine Hydrochloride Ophthalmic Solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 206046
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 |
|---|---|---|---|---|
| Equate Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | WAL-MART STORES, INC., | 79903-319 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | RUGBY LABORATORIES | 0536-1445 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | TARGET CORPORATION | 82442-966 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0867 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-966 |