What is NDC 68083-649?

68083-649 is the product NDC for Alcaftadine, Alcaftadine 2.5 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-649 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-649Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0649Add 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
68083-649-01	68083064901	1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLEMarketed from Mar 1, 2024
68083-649-02	68083064902	2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLEMarketed from Mar 1, 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): Alcaftadine
Generic name (nonproprietary): alcaftadine
Active ingredients: Alcaftadine — 2.5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209706
Marketing start: Mar 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882SPL ID 8c937f90-5ae8-49e9-808d-f3dbd9da1882SPL set ID b94e071d-421d-48ec-a4ea-254aa8af19ffRxCUI 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

N468083064901 followed by a unit qualifier and the quantity

Package 68083-0649-01. 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 Mar 5, 2024.

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 68083-649

What is NDC 68083-649?: 68083-649 is the product NDC for Alcaftadine, Alcaftadine 2.5 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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	Aurohealth LLC	58602-605	58602-0605-4058602-0605-42