55648-107 NDC - BUPROPION HYDROCHLORIDE ()

Drug Information

  • Product NDC: 55648-107
  • Proprietary Name: Bupropion Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Wockhardt Limited
Product Type:
FDA Application Number: ANDA201331
Marketing Category: ANDA
Start Marketing Date:8/30/2012

Package Information

No. Package Code Package Description Billing Unit
155648-107-0130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-01)
255648-107-0260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-02)
355648-107-03100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-03)
455648-107-04500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-107-04)
555648-107-0510 BLISTER PACK in 1 CARTON (55648-107-05) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (55648-107-07)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55648-107The 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.
PROPRIETARY NAMEBupropion HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX(SR)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.
START MARKETING DATE8/30/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA201331This 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 NAMEWockhardt LimitedName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/19/2025

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