What is Azelastine Hydrochloride used for and Azelastine Hydrochloride Product NDC number? Below is the most updated information on the Product NDC number 0054-0293 – Azelastine Hydrochloride drug (Azelastine Hydrochloride). Medical Code Data provides all information of this drug products including NDC product code, labeler name, dosage form & certification date.
What is Azelastine Hydrochloride?
Azelastine Hydrochloride is a HUMAN PRESCRIPTION DRUG labeled by West-Ward Pharmaceuticals Corp.. Azelastine Hydrochloride, commonly known as Azelastine Hydrochloride, is assigned Product NDC number 0054-0293. Azelastine Hydrochloride is marketed under the ANDA category with application number ANDA091444. Azelastine Hydrochloride‘s dosage form is SPRAY, METERED and is administered via NASAL form.
- Proprietary Name / Trade Name: Azelastine Hydrochloride
- Non Proprietary Name / Generic Name: Azelastine Hydrochloride
- Product Type Name: HUMAN PRESCRIPTION DRUG
- Proprietary Name Suffix:
Uses & dosage information
- Dosage Form Name: SPRAY, METERED
- Route Name: NASAL
- Substance Name: AZELASTINE HYDROCHLORIDE
- Active strength Number: 137
- Active Strength Unit: ug/1
- Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
What is Azelastine Hydrochloride used for? We are updating more information on uses, dosage, side effects, warnings, reviews and pictures of Azelastine Hydrochloride (generic name Azelastine Hydrochloride) – Product NDC number 0054-0293 . Please visit MedCodeData.com frequently to get the most updated information
- Marketing Category Name: ANDA
- Labeler Name: West-Ward Pharmaceuticals Corp.
- NDC Exclude Flag: N
- FDA Public: Approved (Please Visit FDA for latest update)
- Product ID: 0054-0293_dede4983-d07f-4461-ad4b-e6dcbd440575
- Product NDC Number: 0054-0293
- Application Number: ANDA091444
- Start Marketing Date: 2014-10-27
- End Marketing Date:–
- Listing Record Certified Through: 2018-12-31
Above are up-to-date information of Azelastine Hydrochloride – 0054-0293. There are no other drug products that have the same NDC identifier number. You can lookup more NDC number by clicking here
Useful information of the NDC Directory by FDA
What is NDC?
NDC (stands for National Drug Code) is a universal product identifier for human drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the United States. An NDC number for a specific drug is created by the the FDA and the manufacturer to ensure that products can be differentiated. The NDC database includes all information submitted to the FDA as part of drug listing requirements under section 510 of the FD&C Act, 21 USC 360.
How is the NDC formatted?
An NDC number contains 3 segments: the labeler code (identifies the manufacturer, repackager or distributor), the product code (identifies a specific strength, dosage form, and formulation) and the package code (identifies package types and sizes).
Important notes regarding NDC
- Assignment of an NDC number does not in any way denote FDA approval of the product.
- Assignment of an NDC number does not denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
- National Drug Code Directory does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients(APIs), drugs for further processing,…
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DISCLAIMER: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.