NDC codes

FDA NDC Directory
Product NDC (as listed)54799-920Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54799-0920Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54799-920-25547990920252.5 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

N454799092025 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 209420
ProductStrengthForm · routeLabelerProduct NDC
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicAlembic Pharmaceuticals Limited46708-710
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicAlembic Pharmaceuticals Inc.62332-502
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicAlembic Pharmaceuticals Inc.62332-710

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