Over-the-counter drug · ANDA
Olopatadine Hydrochloride (Olopatadine hydrochloride ophthalmic) NDC 46122-823
Olopatadine hydrochloride 1 mg/mL · Solution · Ophthalmic · AmerisourceBergen Drug Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-823-29 | 4612208232946122082329 | 1 BOTTLE, PLASTIC in 1 CARTON (46122-823-29) / 5 mL in 1 BOTTLE, PLASTICMarketed from May 1, 2026 |
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
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- AmerisourceBergen Drug CorpNDC labeler code 46122
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200810
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46122-823_ea97d3d8-dc96-4c40-91e7-f076c588bf12SPL ID ea97d3d8-dc96-4c40-91e7-f076c588bf12SPL set ID ea97d3d8-dc96-4c40-91e7-f076c588bf12RxCUI 1111339UNII 2XG66W44KFUPC 0346122823296
- 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
N446122082329followed by a unit qualifier and the quantityPackage 46122-0823-29. 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 46122-823
- What is NDC 46122-823?
- 46122-823 is the product NDC for Olopatadine Hydrochloride (olopatadine hydrochloride ophthalmic), Olopatadine hydrochloride 1 mg/mL solution, listed with the FDA by AmerisourceBergen Drug Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olopatadine Hydrochloride (Olopatadine Hydrochloride ophthalmic).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- AmerisourceBergen Drug Corp, NDC labeler code 46122. 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?
- 63 other product NDCs are listed under this name. See all Olopatadine Hydrochloride 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 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 | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA CORP | 73581-713 | 73581-0713-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA CORP | 73581-712 | 73581-0712-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-824 | 46122-0824-29 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA Corp | 73581-709 | 73581-0709-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0869 | 00363-0869-0100363-0869-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | BluePoint Laboratories | 68001-674 | 68001-0674-92 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Allegiant Health | 69168-480 | 69168-0480-0269168-0480-65 |
| olopatadine hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Rising Pharma Holdings, Inc. | 16571-861 | 16571-0861-25 |
| olopatadine hydrochloride | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Rising Pharma Holdings, Inc. | 16571-882 | 16571-0882-05 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | RUGBY LABORATORIES | 0536-1445 | 00536-1445-40 |
Other NDCs under ANDA 200810
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 Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Golden State Medical Supply, Inc. | 51407-938 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1280 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | GLENMARK THERAPEUTICS INC., USA | 72657-168 |