Over-the-counter drug · ANDA
Olopatadine Hydrochloride Ophthalmic Solution Twice Daily (Olopatadine hydrochloride ophthalmic) NDC 55910-109
Olopatadine hydrochloride 1 mg/mL · Solution/ drops · Ophthalmic · DOLGENCORP, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55910-109-05 | 5591001090555910010905 | 1 BOTTLE, PLASTIC in 1 CARTON (55910-109-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Dec 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 Twice DailySuffix: Twice Daily
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 1 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- DOLGENCORP, LLCNDC labeler code 55910
- 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 55910-109_fb7ff287-49de-f4ae-11fd-1b7726814156SPL ID fb7ff287-49de-f4ae-11fd-1b7726814156SPL set ID a9f03242-b5fa-5762-f9a6-b7c0c5ee46c3RxCUI 1111339UNII 2XG66W44KF
- Pharmacologic class
- Histamine-1 Receptor Inhibitor
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
N455910010905followed by a unit qualifier and the quantityPackage 55910-0109-05. 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 55910-109
- What is NDC 55910-109?
- 55910-109 is the product NDC for Olopatadine Hydrochloride Ophthalmic Solution Twice Daily, Olopatadine hydrochloride 1 mg/mL solution/ drops, listed with the FDA by DOLGENCORP, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olopatadine Hydrochloride Ophthalmic Solution Twice Daily (Olopatadine Hydrochloride Ophthalmic).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- DOLGENCORP, LLC, NDC labeler code 55910. 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 Twice Daily?
- 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 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 |
| 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 Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Chain Drug Marketing Association INC | 63868-822 |
| 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 |