Azelastine Hydrochloride
- Product NDC
- 68071-2497
- 11-digit product format
- 680712497
- Labeler code
- 68071
- Product ID
- 68071-2497_c922833b-e10e-13a4-e053-2995a90abc88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077954
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2497-1 | Azelastine Hydrochloride | 1 in 1 CARTON | SPRAY, METERED | 1 | | 1 |
| 68071-2497-1 | Azelastine Hydrochloride | 200 in 1 BOTTLE, SPRAY | SPRAY, METERED | 200 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2497 | AZELASTINE HYDROCHLORIDE SPRAY, METERED [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 2 package rows | 20210810_c922833b-e10d-13a4-e053-2995a90abc88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2497-1 | 68071249701 | 1 BOTTLE, SPRAY in 1 CARTON (68071-2497-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY | 2021-08-09 | 0000-00-00 | No | No | Current |