Over-the-counter drug · ANDA
Eye Allergy Itch Relief (Olopatadine hcl) NDC 70000-0053
Olopatadine hydrochloride 2 mg/mL · Solution/ drops · Ophthalmic · CARDINAL HEALTH 110, LLC. DBA LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0053-1 | 7000000530170000005301 | 1 BOTTLE, DROPPER in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 15, 2021 |
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)
- Eye Allergy Itch Relief
- Generic name (nonproprietary)
- olopatadine hcl
- Active ingredients
- Olopatadine hydrochloride — 2 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADERNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209752
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0053_ece56087-7def-0eb9-13d3-b187763b7f7bSPL ID ece56087-7def-0eb9-13d3-b187763b7f7bSPL set ID 135bb2de-b2c0-6f0c-6204-3acbb48dcfbdRxCUI 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
N470000005301followed by a unit qualifier and the quantityPackage 70000-0053-01. 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 70000-0053
- What is NDC 70000-0053?
- 70000-0053 is the product NDC for Eye Allergy Itch Relief (olopatadine hcl), Olopatadine hydrochloride 2 mg/mL solution/ drops, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eye Allergy Itch Relief (Olopatadine HCl).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- CARDINAL HEALTH 110, LLC. DBA LEADER, 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 Eye Allergy Itch Relief?
- 5 other product NDCs are listed under this name. See all Eye Allergy Itch Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eye Allergy Itch Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | TARGET CORPORATION | 82442-027 | 82442-0027-2582442-0027-50 |
| Eye Allergy Itch Relief | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Allegiant Health | 69168-495 | 69168-0495-77 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Walgreen Company | 0363-1325 | 00363-1325-0100363-1325-02 |
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0746 | 70000-0746-01 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Dr. Reddy's Laboratories Inc. | 75907-343 | 75907-0343-25 |
Other NDCs under ANDA 209752
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 2 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-675 |
| CVS Eye Allergy Itch Relief Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | CVS Health Corp | 69842-269 |
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Dr. Reddy's Laboratories Inc. | 43598-827 |
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1155 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Rugby Laboratories | 0536-1307 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Walgreens Company | 0363-7131 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Target Corporation | 11673-688 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Rite Aid Corporation | 11822-9975 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Albertsons Companies | 21130-105 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 63868-821 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-231 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 83324-120 |
| Olopatadine Hydrochloride Ophthalmic Solution Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | DOLGENCORP, LLC | 55910-137 |
| Once Daily Reliefolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | H E B | 37808-045 |