Prescription drug · ANDA
Azelastine Hydrochloride Ophthalmic Solution 0.05% NDC 62332-506
Azelastine hydrochloride .5 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-506-06 | 6233205060662332050606 | 1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLEMarketed from Mar 20, 2019 |
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)
- Azelastine Hydrochloride Ophthalmic Solution 0.05%
- Generic name (nonproprietary)
- azelastine hydrochloride ophthalmic solution 0.05%
- Active ingredients
- Azelastine hydrochloride — .5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209620
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62332-506_0857a4e2-caec-4c87-9894-949a549144c3SPL ID 0857a4e2-caec-4c87-9894-949a549144c3SPL set ID 7532ed82-5cfa-49da-83e5-c57ffdd3adbbRxCUI 860805UNII 0L591QR10I
- 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
N462332050606followed by a unit qualifier and the quantityPackage 62332-0506-06. 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)
INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Excerpt only. Read the full label for complete information.
About NDC 62332-506
- What is NDC 62332-506?
- 62332-506 is the product NDC for Azelastine Hydrochloride Ophthalmic Solution 0.05%, Azelastine hydrochloride .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?
- Azelastine Hydrochloride Ophthalmic Solution 0.05%.
- What is the active ingredient?
- Azelastine hydrochloride.
- 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 Azelastine Hydrochloride Ophthalmic Solution 0.05%?
- 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 209620
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 |
|---|---|---|---|---|
| Azelastine Hydrochloride | Azelastine hydrochloride .5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-506 |