NDC 12634-687 Phentermine Hydrochloride
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Product Details
What is NDC 12634-687?
What are the uses for Phentermine Hydrochloride?
Which are Phentermine Hydrochloride UNII Codes?
The UNII codes for the active ingredients in this product are:
- PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV)
- PHENTERMINE (UNII: C045TQL4WP) (Active Moiety)
Which are Phentermine Hydrochloride Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- CROSPOVIDONE (UNII: 68401960MK)
- CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POVIDONES (UNII: FZ989GH94E)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Phentermine Hydrochloride?
- RxCUI: 803353 - phentermine HCl 37.5 MG Oral Tablet
- RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
- RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet
* Please review the disclaimer below.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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".