73208-580 NDC - SAL DE UVAS PICOT (CITRIC ACID MONOHYDRATE AND SODIUM BICARBONATE)

Drug Information

  • Product NDC: 73208-580
  • Proprietary Name: Sal de Uvas Picot
  • Non Proprietary Name: Citric Acid monohydrate and Sodium bicarbonate
  • Active Ingredient(s): 1948.5 mg/1 CITRIC ACID MONOHYDRATE; 2485 mg/1 SODIUM BICARBONATE
  • Administration Route(s): ORAL
  • Dosage Form(s): GRANULE, EFFERVESCENT
  • Pharmacy Class(es): Acidifying Activity [MoA]; Alkalinizing Activity [MoA]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: RB Health Mexico, S.A. de C.V.
Product Type: HUMAN OTC DRUG
FDA Application Number: M001
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:1/7/2022

Package Information

No. Package Code Package Description Billing Unit
173208-580-014 PACKET in 1 CARTON (73208-580-01) / 1 GRANULE, EFFERVESCENT in 1 PACKET
273208-580-026 PACKET in 1 CARTON (73208-580-02) / 1 GRANULE, EFFERVESCENT in 1 PACKET
373208-580-038 PACKET in 1 CARTON (73208-580-03) / 1 GRANULE, EFFERVESCENT in 1 PACKET
473208-580-0412 PACKET in 1 CARTON (73208-580-04) / 1 GRANULE, EFFERVESCENT in 1 PACKET
573208-580-0550 PACKET in 1 CARTON (73208-580-05) / 1 GRANULE, EFFERVESCENT in 1 PACKET

NDC Record

Field Name Field Value Definition
PRODUCT NDC73208-580The 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 OTC 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 NAMESal de Uvas PicotThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECitric Acid monohydrate and Sodium bicarbonateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGRANULE, EFFERVESCENTThe 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 DATE1/7/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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 NUMBERM001This 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 NAMERB Health Mexico, S.A. de C.V.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECITRIC ACID MONOHYDRATE; SODIUM BICARBONATEAn 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 STRENGTH1948.5; 2485 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAcidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] 

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

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