Over-the-counter drug · ANDA
Eye Allergy Itch and Redness Relief (Olopatadine hydrochloride) NDC 70000-0054
Olopatadine hydrochloride 1 mg/mL · Solution/ drops · Ophthalmic · CARDINAL HEALTH 110, LLC. DBA LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0054-1 | 7000000540170000005401 | 1 BOTTLE, DROPPER in 1 CARTON (70000-0054-1) / 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 and Redness Relief
- Generic name (nonproprietary)
- olopatadine hydrochloride
- Active ingredients
- Olopatadine hydrochloride — 1 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 209619
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0054_5104f5a9-ebf6-c7a1-6eb2-f43a025f699fSPL ID 5104f5a9-ebf6-c7a1-6eb2-f43a025f699fSPL set ID 5255d142-7d04-ab80-fa97-b11c4486e42cRxCUI 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
N470000005401followed by a unit qualifier and the quantityPackage 70000-0054-01. 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 and red eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 70000-0054
- What is NDC 70000-0054?
- 70000-0054 is the product NDC for Eye Allergy Itch and Redness Relief, Olopatadine hydrochloride 1 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 and Redness Relief (Olopatadine Hydrochloride).
- 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 and Redness Relief?
- 1 other product NDC are listed under this name. See all Eye Allergy Itch and Redness 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 and Redness 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 and Redness Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Strategic Sourcing Services LLC | 70677-1156 | 70677-1156-01 |
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 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 |
| 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 |