NDC 62756-545 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride with NDC 62756-545 is a a human over the counter drug product labeled by Sun Pharmaceutical Industries, Inc.. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 997420, 997488 and 997501.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fexofenadine Hydrochloride Active Ingredient(s)

• FEXOFENADINE HYDROCHLORIDE 180 mg/1
• FEXOFENADINE HYDROCHLORIDE 180 mg/1

Inactive Ingredient(s)

• CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
• STARCH, CORN (UNII: O8232NY3SJ)
• CROSPOVIDONE (UNII: 68401960MK)
• MAGNESIUM STEARATE (UNII: 70097M6I30)
• HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
• POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
• FERRIC OXIDE RED (UNII: 1K09F3G675)
• FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
• CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
• STARCH, CORN (UNII: O8232NY3SJ)
• CROSPOVIDONE (UNII: 68401960MK)
• MAGNESIUM STEARATE (UNII: 70097M6I30)
• HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
• POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
• FERRIC OXIDE RED (UNII: 1K09F3G675)
• FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
• CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
• STARCH, CORN (UNII: O8232NY3SJ)
• CROSPOVIDONE (UNII: 68401960MK)
• MAGNESIUM STEARATE (UNII: 70097M6I30)
• HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
• POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
• FERRIC OXIDE RED (UNII: 1K09F3G675)
• FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Administration Route(s)

• Oral - Administration to or by way of the mouth.
• Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

• Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
• Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
• Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
• Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

Labeler Name: Sun Pharmaceutical Industries, Inc.
Labeler Code: 62756
FDA Application Number: ANDA091567 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 02-06-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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