What is NDC 58602-605?

58602-605 is the product NDC for Alcaftadine, Alcaftadine 2.5 mg/mL solution/ drops, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alcaftadine?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alcaftadine NDC 58602-605 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-605Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0605Add 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 NDC	11-digit (billing)	Package	Copy
58602-605-40	5860206054058602060540	1 BOTTLE in 1 CARTON (58602-605-40) / 5 mL in 1 BOTTLEMarketed from Jun 23, 2023
58602-605-42	5860206054258602060542	2 BOTTLE in 1 CARTON (58602-605-42) / 5 mL in 1 BOTTLEMarketed from Jun 23, 2023

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): Alcaftadine
Generic name (nonproprietary): alcaftadine
Active ingredients: Alcaftadine — 2.5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Aurohealth LLCNDC labeler code 58602
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210659
Marketing start: Jun 23, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-605_d550d462-ab7c-4703-9e6d-3b2360abac7dSPL ID d550d462-ab7c-4703-9e6d-3b2360abac7dSPL set ID d550d462-ab7c-4703-9e6d-3b2360abac7dRxCUI 1000085UNII 7Z8O94ECSX
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N458602060540 followed by a unit qualifier and the quantity

Package 58602-0605-40. 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 Jun 23, 2023.

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 58602-605

What is NDC 58602-605?: 58602-605 is the product NDC for Alcaftadine, Alcaftadine 2.5 mg/mL solution/ drops, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alcaftadine.
What is the active ingredient?: Alcaftadine.
Who is the labeler?: Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alcaftadine?: 2 other product NDCs are listed under this name. See all Alcaftadine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Alcaftadine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
alcaftadine	Alcaftadine 2.5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-147	62332-0147-03
Alcaftadine	Alcaftadine 2.5 mg/mL	Solution/ dropsOphthalmic	Gland Pharma Limited	68083-649	68083-0649-0168083-0649-02