Over-the-counter drug · ANDA
Leader Olopatadine Hydrochloride (Olopatadine hydrochloride) NDC 70000-0716
Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · CARDINAL HEALTH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0716-1 | 7000007160170000071601 | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1) / 3.5 mL in 1 BOTTLE, PLASTICMarketed 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
- Generic name (nonproprietary)
- olopatadine hydrochloride
- Active ingredients
- Olopatadine hydrochloride — 2 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 206087
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29SPL ID 32c153a7-d51f-72c5-e063-6294a90aee29SPL set ID 71d922d2-22a5-4103-a3eb-126094ee8ef5RxCUI 1111343UNII 2XG66W44KF
- 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
N470000071601followed by a unit qualifier and the quantityPackage 70000-0716-01. 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)
Uses temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 70000-0716
- What is NDC 70000-0716?
- 70000-0716 is the product NDC for Leader Olopatadine Hydrochloride (olopatadine hydrochloride), Olopatadine hydrochloride 2 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 (Olopatadine hydrochloride).
- 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?
- 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 206087
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 Hydrochlorideolopatadine hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | WAL-MART STORES, INC., | 79903-318 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0869 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-617 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-967 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | TARGET CORPORATION | 82442-967 |