Over-the-counter drug · ANDA
Olopatadine Hydrochloride Ophthalmic Solution (Olopatadine hydrochloride ophthalmic) NDC 68083-398
Olopatadine hydrochloride 7 mg/mL · Solution · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68083-398Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68083-0398Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-398-01 | 6808303980168083039801 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jan 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)
- Olopatadine Hydrochloride Ophthalmic Solution
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 7 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213514
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68083-398_e05ea1df-8db8-4261-be59-8f303da3b57eSPL ID e05ea1df-8db8-4261-be59-8f303da3b57eSPL set ID a3475f8c-c780-43c0-b22f-08a0ce5608fdRxCUI 1601086UNII 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
N468083039801followed by a unit qualifier and the quantityPackage 68083-0398-01. 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)
USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 68083-398
- What is NDC 68083-398?
- 68083-398 is the product NDC for Olopatadine Hydrochloride Ophthalmic Solution, Olopatadine hydrochloride 7 mg/mL solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olopatadine Hydrochloride Ophthalmic Solution (Olopatadine hydrochloride ophthalmic).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olopatadine Hydrochloride Ophthalmic Solution?
- 17 other product NDCs are listed under this name. See all Olopatadine Hydrochloride Ophthalmic Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olopatadine Hydrochloride Ophthalmic Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-567 | 51316-0567-01 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0867 | 00363-0867-01 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | TARGET CORPORATION | 82442-967 | 82442-0967-02 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-966 | 24208-0966-0124208-0966-02 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Target Corporation | 11673-689 | 11673-0689-05 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Target Corporation | 11673-688 | 11673-0688-25 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Albertsons Companies | 21130-105 | 21130-0105-02 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 63868-821 | 63868-0821-25 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Chain Drug Marketing Association INC | 63868-822 | 63868-0822-05 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 83324-120 | 83324-0120-25 |
Other NDCs under ANDA 213514
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 |
|---|---|---|---|---|
| Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-633 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Walgreen Company | 0363-1325 |
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0746 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Dr. Reddy's Laboratories Inc. | 75907-343 |
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | TARGET CORPORATION | 82442-027 |
| Olopatadine HClolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | Rugby Laboratories | 0536-1478 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-567 |