Over-the-counter drug · ANDA
Olopatadine Hydrochloride Ophthalmic Solution (Olopatadine hydrochloride ophthalmic) NDC 63868-822
Olopatadine hydrochloride 1 mg/mL · Solution/ drops · Ophthalmic · Chain Drug Marketing Association INC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63868-822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0822Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-822-05 | 6386808220563868082205 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-822-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jan 1, 2021 |
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 — 1 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Chain Drug Marketing Association INCNDC labeler code 63868
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209619
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63868-822_8a32aa43-e0cf-f950-04b1-2a30384d2674SPL ID 8a32aa43-e0cf-f950-04b1-2a30384d2674SPL set ID 5fa34b50-ffa3-4090-86f9-436f32f45ceaRxCUI 1111339UNII 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
N463868082205followed by a unit qualifier and the quantityPackage 63868-0822-05. 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 and red eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 63868-822
- What is NDC 63868-822?
- 63868-822 is the product NDC for Olopatadine Hydrochloride Ophthalmic Solution, Olopatadine hydrochloride 1 mg/mL solution/ drops, listed with the FDA by Chain Drug Marketing Association INC. 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?
- Chain Drug Marketing Association INC, NDC labeler code 63868. 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 Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-398 | 68083-0398-01 |
| 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 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 83324-120 | 83324-0120-25 |
Other NDCs under ANDA 209619
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 |
|---|---|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-477 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Dr. Reddy's Laboratories Inc. | 43598-765 |
| Eye Allergy Itch and Redness Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Strategic Sourcing Services LLC | 70677-1156 |
| Olopatadine Hydrochloride Ophthalmic Solution Twice Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | DOLGENCORP, LLC | 55910-109 |
| Eye Allergy Itch and Redness Relief Twice Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Dr. Reddy's Laboratories Inc. | 43598-826 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Target Corporation | 11673-689 |
| CVS Eye Allergy Itch Relief Twice Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | CVS Health Corp | 69842-268 |
| Eye Allergy Itch and Redness Reliefolopatadine hydrochloride | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0054 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Walgreens Company | 0363-7130 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Rite Aid Corporation | 11822-9976 |