Over-the-counter drug · ANDA
Azelastine Hydrochloride NDC 51316-840
Azelastine hydrochloride 205.5 ug/1 · Spray, Metered · Nasal · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-840-01 | 5131608400151316084001 | 1 BOTTLE, SPRAY in 1 CARTON (51316-840-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02)Marketed from Aug 1, 2025 | |
| 51316-840-02 | 5131608400251316084002 | 120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02)Marketed from Aug 1, 2025 | |
| 51316-840-03 | 5131608400351316084003 | 1 BOTTLE, SPRAY in 1 CARTON (51316-840-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Aug 1, 2025 | |
| 51316-840-04 | 5131608400451316084004 | 60 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-04)Marketed from Aug 1, 2025 | |
| 51316-840-05 | 5131608400551316084005 | 2 BOTTLE, SPRAY in 1 CARTON (51316-840-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Aug 1, 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
- CVS PHARMACY, INCNDC labeler code 51316
- 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 51316-840_581af55f-af37-4520-ba01-4a42e38c1b72SPL ID 581af55f-af37-4520-ba01-4a42e38c1b72
- 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
N451316084001followed by a unit qualifier and the quantityPackage 51316-0840-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51316-840
- What is NDC 51316-840?
- 51316-840 is the product NDC for Azelastine Hydrochloride, Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by CVS PHARMACY, INC. It has 5 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?
- CVS PHARMACY, INC, NDC labeler code 51316. 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 | 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 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 | Allegiant Health | 69168-479 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-478 |
| Azelastine Hydrochloride | Azelastine hydrochloride 205.5 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0653 |