Prescription drug · ANDA
Azelastine Hydrochloride NDC 71205-449
Azelastine hydrochloride 137 ug/1 · Spray, Metered · Nasal · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-449-30 | 7120504493071205044930 | 1 BOTTLE, SPRAY in 1 CARTON (71205-449-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Apr 1, 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
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077954
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71205-449_91c72454-515f-4966-ad84-a78aba616fb5SPL ID 91c72454-515f-4966-ad84-a78aba616fb5SPL set ID 11a74cae-a15b-4a6b-a8c0-1e6a234ee258RxCUI 1797867UNII 0L591QR10IUPC 0371205449308
- 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
N471205044930followed by a unit qualifier and the quantityPackage 71205-0449-30. 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 H1-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 71205-449
- What is NDC 71205-449?
- 71205-449 is the product NDC for Azelastine Hydrochloride, Azelastine hydrochloride 137 ug/1 spray, metered, listed with the FDA by Proficient Rx LP. 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?
- Proficient Rx LP, NDC labeler code 71205. 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 077954
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 | 50090-2330 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-0833 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals Inc. | 68788-4056 |