Prescription drug · ANDA
Azelastine Hydrochloride NDC 59651-214
Azelastine hydrochloride 137 ug/1 · Spray, Metered · Nasal · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-214-30 | 5965102143059651021430 | 1 BOTTLE, SPRAY in 1 CARTON (59651-214-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from May 8, 2020 |
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 — 137 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212289
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 59651-214_c3f16181-99f1-406c-b795-d33ff0da7ef6SPL ID c3f16181-99f1-406c-b795-d33ff0da7ef6SPL set ID 97c91a09-98d0-4666-8448-0bd50c02bb14RxCUI 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
N459651021430followed by a unit qualifier and the quantityPackage 59651-0214-30. 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 Nasal Spray 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 hydrochloride Nasal Spray 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 59651-214
- What is NDC 59651-214?
- 59651-214 is the product NDC for Azelastine Hydrochloride, Azelastine hydrochloride 137 ug/1 spray, metered, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 Hydrochlorideazelastine | Azelastine hydrochloride 1 mg/mL | Spray, MeteredNasal | AvKARE | 42291-094 | 42291-0094-30 |
Other NDCs under ANDA 212289
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 137 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-7461 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals Inc. | 68788-8514 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | NorthStar Rx LLC | 72603-611 |