21695-178 NDC - PRAVASTATIN SODIUM ()

Drug Information

  • Product NDC: 21695-178
  • Proprietary Name: Pravastatin Sodium
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Rebel Distributors Corp
Product Type:
FDA Application Number: ANDA076939
Marketing Category: ANDA
Start Marketing Date:10/23/2006

Package Information

No. Package Code Package Description Billing Unit
121695-178-3030 TABLET in 1 BOTTLE, PLASTIC (21695-178-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC21695-178Indicates 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.
PROPRIETARY NAMEPravastatin SodiumThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE10/23/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAThe translation of the dosage form Code submitted by the firm.
APPLICATION NUMBERANDA076939This 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 NAMERebel Distributors CorpThis is the date that the labeler indicates was the start of its marketing of the drug product.

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