NDC 76168-015 Sleep Aid

Sleep Aid with NDC 76168-015 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Sleep Aid is diphenhydramine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

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.

Sleep Aid Active Ingredient(s)

• DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

RxNorm Crosswalk

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

• RxCUI: 1049630

Inactive Ingredient(s)

• CARNAUBA WAX (UNII: R12CBM0EIZ)
• CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
• FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
• ALUMINUM OXIDE (UNII: LMI26O6933)
• HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
• MAGNESIUM STEARATE (UNII: 70097M6I30)
• MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
• POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
• POLYSORBATE 80 (UNII: 6OZP39ZG8H)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

• 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)

Product Labeler Information

Labeler Name: Velocity Pharma Llc
Labeler Code: 76168
FDA Application Number: part338 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-14-2018 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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