0121-0531 NDC - PHENOBARBITAL

Drug Information

Product NDC: 0121-0531

Proprietary Name: Phenobarbital

Non Proprietary Name: Phenobarbital

Active Ingredient(s):
  • 20 mg/5mL PHENOBARBITAL


Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Labeler Information

Labeler Name: Pharmaceutical Associates, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/19/2007
DEA Schedule:CIV

Package Information

No. Package Code Package Description Billing Unit
10121-0531-0510 TRAY in 1 CASE (0121-0531-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
20121-0531-0710 TRAY in 1 CASE (0121-0531-07) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE
30121-0531-1510 TRAY in 1 CASE (0121-0531-15) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE
40121-0531-1612 BOTTLE in 1 CASE (0121-0531-16) / 473 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0121-0531The 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 DRUGIndicates 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 NAMEPhenobarbitalThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPhenobarbitalThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/19/2007This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEPharmaceutical Associates, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPHENOBARBITALAn 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 STRENGTH20 
ACTIVE INGRED UNITmg/5mL 
DEA SCHEDULECIVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 2/1/2023