68788-8558 NDC - CLINDAMYCIN HYDROCHLORIDE

Drug Information

  • Product NDC: 68788-8558
  • Proprietary Name: Clindamycin Hydrochloride
  • Non Proprietary Name: Clindamycin Hydrochloride
  • Active Ingredient(s): 150 mg/1 CLINDAMYCIN HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE
  • Pharmacy Class(es): Decreased Sebaceous Gland Activity [PE]; Lincosamide Antibacterial [EPC]; Lincosamides [CS]; Neuromuscular Blockade [PE]

Labeler Information

Field Name Field Value
Labeler Name: Preferred Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA216957
Marketing Category: ANDA
Start Marketing Date:12/21/2023

Package Information

No. Package Code Package Description Billing Unit
168788-8558-012 CAPSULE in 1 BOTTLE (68788-8558-0)
268788-8558-114 CAPSULE in 1 BOTTLE (68788-8558-1)
368788-8558-220 CAPSULE in 1 BOTTLE (68788-8558-2)
468788-8558-330 CAPSULE in 1 BOTTLE (68788-8558-3)
568788-8558-556 CAPSULE in 1 BOTTLE (68788-8558-5)EA
668788-8558-660 CAPSULE in 1 BOTTLE (68788-8558-6)
768788-8558-721 CAPSULE in 1 BOTTLE (68788-8558-7)
868788-8558-828 CAPSULE in 1 BOTTLE (68788-8558-8)

NDC Record

Field Name Field Value Definition
PRODUCT NDC68788-8558The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PROPRIETARY NAMEClindamycin Hydrochloride 
NON PROPRIETARY NAMEClindamycin Hydrochloride 
DOSAGE FORM NAMECAPSULEA 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.
ROUTE NAMEORALThis is the date that the labeler indicates was the start of its marketing of the drug product.
START MARKETING DATE12/21/2023Product 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.
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 NUMBERANDA216957This 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 NAMEPreferred Pharmaceuticals Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECLINDAMYCIN HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH150 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESDecreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]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.

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This page was last updated on: 12/6/2025

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