Over-the-counter drug · ANDA
Retaine Allergy (Olopatadine hydrochloride) NDC 54799-920
Olopatadine hydrochloride 5 mg/2.5mL · Solution/ drops · Ophthalmic · OCuSOFT LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54799-920-25 | 54799092025 | 2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25)Marketed from Jul 5, 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)
- Retaine Allergy
- Generic name (nonproprietary)
- olopatadine hydrochloride
- Active ingredients
- Olopatadine hydrochloride — 5 mg/2.5mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- OCuSOFT LLCNDC labeler code 54799
- 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 54799-920_575c94a5-ec98-4050-a450-2a6c4ef95641SPL ID 575c94a5-ec98-4050-a450-2a6c4ef95641SPL set ID e0a01606-275d-448c-8838-ca46f1e612e5RxCUI 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
N454799092025followed by a unit qualifier and the quantityPackage 54799-0920-25. 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 54799-920
- What is NDC 54799-920?
- 54799-920 is the product NDC for Retaine Allergy (olopatadine hydrochloride), Olopatadine hydrochloride 5 mg/2.5mL solution/ drops, listed with the FDA by OCuSOFT LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Retaine Allergy (Olopatadine hydrochloride).
- What is the active ingredient?
- Olopatadine hydrochloride.
- Who is the labeler?
- OCuSOFT LLC, NDC labeler code 54799. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Retaine Allergy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 Limited | 46708-710 |
| 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 |