Over-the-counter drug · ANDA
alcaftadine NDC 62332-147
Alcaftadine 2.5 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-147-03 | 62332014703 | 1 BOTTLE in 1 CARTON (62332-147-03) / 3 mL in 1 BOTTLEMarketed from Oct 2, 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
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209290
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62332-147_64d45e8d-158b-42f2-84aa-14fc849eaf0eSPL ID 64d45e8d-158b-42f2-84aa-14fc849eaf0eSPL set ID 22473109-dc9e-45b6-b188-d7d5773f5a14RxCUI 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
N462332014703followed by a unit qualifier and the quantityPackage 62332-0147-03. 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 62332-147
- What is NDC 62332-147?
- 62332-147 is the product NDC for alcaftadine, Alcaftadine 2.5 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, 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?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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.
Related NDCs: other alcaftadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alcaftadine | Alcaftadine 2.5 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-649 | 68083-0649-0168083-0649-02 |
| Alcaftadine | Alcaftadine 2.5 mg/mL | Solution/ dropsOphthalmic | Aurohealth LLC | 58602-605 | 58602-0605-4058602-0605-42 |