Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 0536-1307
Olopatadine hydrochloride 2 mg/mL · Solution/ drops · Ophthalmic · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1307-23 | 0053613072300536130723 | 1 BOTTLE, DROPPER in 1 CARTON (0536-1307-23) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 15, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Rugby LaboratoriesNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209752
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0536-1307_ebf26e25-d073-ca39-6b0b-dec0fa2c2107SPL ID ebf26e25-d073-ca39-6b0b-dec0fa2c2107SPL set ID 95424539-7883-2da3-8a46-3d1a19259e15RxCUI 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
N400536130723followed by a unit qualifier and the quantityPackage 00536-1307-23. 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 eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
About NDC 0536-1307
- What is NDC 0536-1307?
- 0536-1307 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 2 mg/mL solution/ drops, listed with the FDA by Rugby Laboratories. 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?
- Rugby Laboratories, NDC labeler code 0536. 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 209752
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 |
|---|---|---|---|---|
| Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-675 |
| CVS Eye Allergy Itch Relief Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | CVS Health Corp | 69842-269 |
| Eye Allergy Itch Reliefolopatadine hcl | Olopatadine hydrochloride 2 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0053 |
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Dr. Reddy's Laboratories Inc. | 43598-827 |
| Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1155 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Walgreens Company | 0363-7131 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Target Corporation | 11673-688 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Rite Aid Corporation | 11822-9975 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Albertsons Companies | 21130-105 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 63868-821 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-231 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Chain Drug Marketing Association INC | 83324-120 |
| Olopatadine Hydrochloride Ophthalmic Solution Once Dailyolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | DOLGENCORP, LLC | 55910-137 |
| Once Daily Reliefolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | H E B | 37808-045 |