PRODUCT NDC | 68788-9806 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
PROPRIETARY NAME | Diclofenac Sodium | This is the date that the labeler indicates was the start of its marketing of the drug product. |
PROPRIETARY NAME SUFFIX | Delayed Release | Name of Company corresponding to the labeler code segment of the Product NDC. |
NON PROPRIETARY NAME | Diclofenac Sodium | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
DOSAGE FORM NAME | TABLET, DELAYED RELEASE | The translation of the dosage form Code submitted by the firm. |
ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
START MARKETING DATE | 8/31/2015 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
MARKETING CATEGORY NAME | ANDA | 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. |
APPLICATION NUMBER | ANDA075185 | 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. |
LABELER NAME | Preferred Pharmaceuticals Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
SUBSTANCE NAME | DICLOFENAC SODIUM | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
ACTIVE NUMERATOR STRENGTH | 75 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
ACTIVE INGRED UNIT | mg/1 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
PHARM CLASSES | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] | |