Over-the-counter drug · ANDA
Olopatadine NDC 70069-017
Olopatadine hydrochloride 1 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-017-01 | 7006900170170069001701 | 1 BOTTLE, PLASTIC in 1 CARTON (70069-017-01) / 5 mL in 1 BOTTLE, PLASTICMarketed from Apr 15, 2024 |
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
- Generic name (nonproprietary)
- olopatadine
- Active ingredients
- Olopatadine hydrochloride — 1 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206306
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70069-017_9cb75ee7-d7e0-4f19-8088-05426d8ea407SPL ID 9cb75ee7-d7e0-4f19-8088-05426d8ea407SPL set ID 55142e80-c5db-46a5-85a5-e8a040bcc8cfRxCUI 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
N470069001701followed by a unit qualifier and the quantityPackage 70069-0017-01. 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 and red eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 70069-017
- What is NDC 70069-017?
- 70069-017 is the product NDC for Olopatadine, Olopatadine hydrochloride 1 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olopatadine.
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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?
- 1 other product NDC are listed under this name. See all Olopatadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olopatadine 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 | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7959 | 50090-7959-00 |
Other NDCs under ANDA 206306
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 | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7959 |