68210-3021 NDC - LACTASE ENZYME AND SODIUM

Drug Information

  • Product NDC: 68210-3021
  • Proprietary Name:
  • Non Proprietary Name: Lactase Enzyme and Sodium
  • Active Ingredient(s): 50 mg/1 LACTASE; 5 mg/1 SODIUM
  • Administration Route(s):
  • Dosage Form(s): CAPSULE, LIQUID FILLED

Labeler Information

Field Name Field Value
Labeler Name: Spirit Pharmaceuticals LLC
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:3/7/2019

Package Information

No. Package Code Package Description Billing Unit
168210-3021-048 POUCH in 1 BOX (68210-3021-0) / 750 CAPSULE, LIQUID FILLED in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC68210-3021The 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 NAMEDRUG FOR FURTHER PROCESSINGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELactase Enzyme and SodiumThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMECAPSULE, LIQUID FILLEDProduct 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 DATE3/7/2019This 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 NAMEDRUG FOR FURTHER PROCESSINGName of Company corresponding to the labeler code segment of the Product NDC.
LABELER NAMESpirit Pharmaceuticals LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELACTASE; SODIUMAn 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 STRENGTH50; 5 
ACTIVE INGRED UNITmg/1; mg/1 

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This page was last updated on: 1/2/2026

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