Prescription drug · ANDA
Azelastine Hydrochloride (Azelastine) NDC 42291-094
Azelastine hydrochloride 1 mg/mL · Spray, Metered · Nasal · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-094-30 | 4229100943042291009430 | 1 BOTTLE, SPRAY in 1 CARTON (42291-094-30) / 30 mL in 1 BOTTLE, SPRAYMarketed from Mar 3, 2021 |
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
- Generic name (nonproprietary)
- azelastine
- Active ingredients
- Azelastine hydrochloride — 1 mg/mL
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204660
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 42291-094_485b8c18-0782-37ea-e063-6394a90ad61eSPL ID 485b8c18-0782-37ea-e063-6394a90ad61eSPL set ID bca75501-4140-4d77-e053-2a95a90a019fRxCUI 1797867UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442291009430followed by a unit qualifier and the quantityPackage 42291-0094-30. 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)
Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine HCl nasal spray, 0.1% is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
Excerpt only. Read the full label for complete information.
About NDC 42291-094
- What is NDC 42291-094?
- 42291-094 is the product NDC for Azelastine Hydrochloride (azelastine), Azelastine hydrochloride 1 mg/mL spray, metered, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azelastine Hydrochloride (Azelastine).
- What is the active ingredient?
- Azelastine hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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?
- 23 other product NDCs are listed under this name. See all Azelastine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azelastine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | YYBA Corp | 73581-500 | 73581-0500-0173581-0500-02 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals Inc. | 68788-4056 | 68788-4056-02 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | CVS PHARMACY, INC | 51316-840 | 51316-0840-0151316-0840-0251316-0840-03+2 more |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0653 | 00363-0653-0200363-0653-0300363-0653-04+1 more |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | NorthStar Rx LLC | 72603-611 | 72603-0611-01 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-478 | 69168-0478-0269168-0478-63 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-479 | 69168-0479-64 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Aurohealth LLC | 58602-020 | 58602-0020-0758602-0020-5158602-0020-52 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals Inc. | 68788-8514 | 68788-8514-02 |
| Azelastine Hydrochloride | Azelastine hydrochloride .5 mg/mL | Solution/ dropsIntraocular | Fosun Pharma USA Inc | 72266-141 | 72266-0141-01 |
Other NDCs under ANDA 204660
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 Hydrochlorideazelastine | Azelastine hydrochloride 1 mg/mL | Spray, MeteredNasal | Amneal Pharmaceuticals LLC | 65162-676 |