Over-the-counter drug · ANDA
Azelastine Hydrochloride NDC 69168-478
Azelastine hydrochloride 205.5 ug/1 · Spray, Metered · Nasal · Allegiant Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-478-02 | 6916804780269168047802 | 2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Sep 22, 2025 | |
| 69168-478-63 | 6916804786369168047863 | 1 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Sep 22, 2025 |
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 hydrochloride
- Active ingredients
- Azelastine hydrochloride — 205.5 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216421
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29SPL ID fc930f5c-a2b9-4e66-814d-ca8d68cc2d29SPL set ID 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112RxCUI 1797883UNII 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
N469168047802followed by a unit qualifier and the quantityPackage 69168-0478-02. 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(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Excerpt only. Read the full label for complete information.
About NDC 69168-478
- What is NDC 69168-478?
- 69168-478 is the product NDC for Azelastine Hydrochloride, Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Allegiant Health. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azelastine Hydrochloride.
- What is the active ingredient?
- Azelastine hydrochloride.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. 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 | 69168-479 | 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 Hydrochlorideazelastine | Azelastine hydrochloride 1 mg/mL | Spray, MeteredNasal | AvKARE | 42291-094 | 42291-0094-30 |
| Azelastine Hydrochloride | Azelastine hydrochloride .5 mg/mL | Solution/ dropsIntraocular | Fosun Pharma USA Inc | 72266-141 | 72266-0141-01 |
Other NDCs under ANDA 216421
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 205.5 ug/1 | Spray, MeteredNasal | CVS PHARMACY, INC | 51316-840 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-479 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0653 |