Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 72657-194
Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · GLENMARK THERAPEUTICS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72657-194-11 | 7265701941172657019411 | 2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2025 | |
| 72657-194-25 | 7265701942572657019425 | 1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2025 |
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
- Active ingredients
- Olopatadine hydrochloride — 2 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- GLENMARK THERAPEUTICS INC., USANDC labeler code 72657
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219557
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72657-194_5ce14b14-b893-4d56-a19e-b1788b17074fSPL ID 5ce14b14-b893-4d56-a19e-b1788b17074fSPL set ID 07e8b359-d4ae-4b5b-81dc-c7e57e172c58RxCUI 1111343UNII 2XG66W44KFUPC 0372657194259
- 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
N472657019411followed by a unit qualifier and the quantityPackage 72657-0194-11. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 72657-194
- What is NDC 72657-194?
- 72657-194 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 2 mg/mL solution, listed with the FDA by GLENMARK THERAPEUTICS INC., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olopatadine Hydrochloride.
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- GLENMARK THERAPEUTICS INC., USA, NDC labeler code 72657. 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 Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-823 | 46122-0823-29 |
| 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 |
Other NDCs under ANDA 219557
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 |
|---|---|---|---|---|
| Eye Allergy Itch Relief | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Allegiant Health | 69168-495 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-824 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | BluePoint Laboratories | 68001-674 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA Corp | 73581-709 |