Azelastine Hydrochloride
- Product NDC
- 0363-0653
- Requested package NDC
- 0363-0653-03
- 11-digit product format
- 003630653
- Labeler code
- 0363
- Product ID
- 0363-0653_52478468-e6b9-4d34-9822-ee138abdecd8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Azelastine Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Walgreens
- Application
- ANDA216421
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 205.5 ug/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | ||
| A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 1e350fbaab3a… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azelastine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AZELASTINE HYDROCHLORIDE | 205.5 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0L591QR10I | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1797883 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ec268981-433f-b26b-4ff0-3a121e0a0d08 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33 | Product name | 3 | 20260126 |
| 85ee67c3-6973-4172-9ada-b124d28b42f8 | Product name | 5 | 20210528 |
| 6397aa5d-11e2-42ce-b46f-ac49599ccf00 | Product name | 5 | 20201006 |
| 033d5d5b-187f-1f40-1e5a-11d732813f92 | Product name | 4 | 20200626 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0653-01 | Azelastine Hydrochloride | 60 in 1 BOTTLE, SPRAY | SPRAY, METERED | 60 | 6 | |
| 0363-0653-02 | Azelastine Hydrochloride | 120 in 1 BOTTLE, SPRAY | SPRAY, METERED | 120 | 6 | |
| 0363-0653-03 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | 6 | |
| 0363-0653-04 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | 6 | |
| 0363-0653-05 | Azelastine Hydrochloride | 120 in 1 BOTTLE, SPRAY | SPRAY, METERED | 120 | 6 | |
| 0363-0653-05 | Azelastine Hydrochloride | 2 in 1 CARTON | SPRAY, METERED | 2 | 6 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Azelastine Hydrochloride | AZELASTINE HYDROCHLORIDE | CVS PHARMACY, INC | 22d516d0-da22-4e3b-a4a5-135b009bc968 | 2026-05-21 | Warnings | 216421 ANDA216421 |
| Azelastine Hydrochloride | AZELASTINE HYDROCHLORIDE | Walgreens | ec268981-433f-b26b-4ff0-3a121e0a0d08 | 2026-04-16 | Warnings | 216421 ANDA216421 0363-0653-03 0363-0653 00363065303 |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | Allegiant Health | cc7ddac6-95fa-4bc0-824d-f80e404e8d32 | 2025-05-02 | Warnings | 216421 ANDA216421 |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | Allegiant Health | 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112 | 2025-05-02 | Warnings | 216421 ANDA216421 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1797883 | azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray | PSN | ec268981-433f-b26b-4ff0-3a121e0a0d08 | 6 |
| 1797883 | azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray | SCD | ec268981-433f-b26b-4ff0-3a121e0a0d08 | 6 |
| 1797883 | azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray | SY | ec268981-433f-b26b-4ff0-3a121e0a0d08 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0363-0653-03 | 00363065303 | 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01) | 2025-07-01 | No | No | Current |