Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 46708-710
Olopatadine hydrochloride 2 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-710-03 | 46708071003 | 1 BOTTLE in 1 CARTON (46708-710-03) / 2.5 mL in 1 BOTTLEMarketed from Jan 25, 2021 |
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/ drops
- Route
- Ophthalmic
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209420
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-710_44d2c756-9e6f-415c-98da-4ee051ebbf24SPL ID 44d2c756-9e6f-415c-98da-4ee051ebbf24SPL set ID ba550d08-a2de-45e7-b053-6bbecdff138bRxCUI 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
N446708071003followed by a unit qualifier and the quantityPackage 46708-0710-03. 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(S) temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 46708-710
- What is NDC 46708-710?
- 46708-710 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 2 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 209420
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 | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-502 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-710 |
| Retaine Allergyolopatadine hydrochloride | Olopatadine hydrochloride 5 mg/2.5mL | Solution/ dropsOphthalmic | OCuSOFT LLC | 54799-920 |