Astelin
- Product NDC
- 0037-0241
- 11-digit product format
- 000370241
- Labeler code
- 0037
- Product ID
- 0037-0241_cc3b2ad8-2a5a-4d87-9831-715a81bd3549
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Meda Pharmaceuticals
- Application
- NDA020114
- Marketing category
- NDA
- Marketing start
- 1996-11-01
- Marketing end
- 0000-00-00
- Substance
- AZELASTINE HYDROCHLORIDE
- Active strength
- 137 ug/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0037-0241-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3038-f274-e053-dbdaa90a6471 | 46b2ddff-d40a-43ac-b027-4fac9fc2f4b9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0037-0241-30 | ML - Milliliter | 0037-0241 | 6c9e09b3-7926-4a06-8b35-ceb9398e9f1b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0L591QR10I | ASTELIN (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| AZELASTINE | ACTIVE MOIETY | ZQI909440X | ASTELIN (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | ASTELIN (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1797876 | Astelin 137 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |
| 1797867 | azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |
| 1797876 | azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray [Astelin] | SBD | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |
| 1797867 | azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray | SCD | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |
| 1797876 | Astelin 0.137 MG/ACTUAT Metered Dose Nasal Spray | SY | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |
| 1797867 | azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray | SY | 944349ca-7cdb-441a-8fd0-b8616857d338 | 1 |