58264-0209 NDC - N-11 (CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLAND)

Drug Information

Product NDC: 58264-0209
Proprietary Name: N-11
Non Proprietary Name: CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, Phosphorus, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, and BOS TAURUS PROSTATE GLAND
Active Ingredient(s): 6 [hp_X]/mL ANEMONE PULSATILLA; 200 [hp_X]/mL BOS TAURUS ADRENAL GLAND; 200 [hp_X]/mL BOS TAURUS PITUITARY GLAND, POSTERIOR; 200 [hp_X]/mL BOS TAURUS PROSTATE GLAND; 6 [hp_X]/mL CINCHONA OFFICINALIS BARK; 6 [hp_X]/mL DIBASIC POTASSIUM PHOSPHATE; 6 [hp_X]/mL PHOSPHORIC ACID; 6 [hp_X]/mL PHOSPHORUS; 6 [hp_X]/mL PICRIC ACID; 200 [hp_X]/mL SUS SCROFA TESTICLE
Administration Route(s): SUBLINGUAL
Dosage Form(s): SOLUTION

Labeler Information

Field Name	Field Value
Labeler Name:	DNA Labs, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	1/1/1990

Package Information

No.	Package Code	Package Description	Billing Unit
1	58264-0209-1	29.57 mL in 1 BOTTLE, GLASS (58264-0209-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	58264-0209	The 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 NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	N-11	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, Phosphorus, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, and BOS TAURUS PROSTATE GLAND	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	SUBLINGUAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	1/1/1990	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	DNA Labs, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ANEMONE PULSATILLA; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS PROSTATE GLAND; CINCHONA OFFICINALIS BARK; DIBASIC POTASSIUM PHOSPHATE; PHOSPHORIC ACID; PHOSPHORUS; PICRIC ACID; SUS SCROFA TESTICLE	An 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 STRENGTH	6; 200; 200; 200; 6; 6; 6; 6; 6; 200
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

58264-0209 NDC - N-11 (CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLAND)

Drug Information

Labeler Information

Package Information

NDC Record

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