NDC 0536-1206 Calcium Carbonate 10 Gr (648 Mg) (antacid)

Calcium Carbonate 10gr (648 Mg)

NDC Product Code 0536-1206

NDC Code: 0536-1206

Proprietary Name: Calcium Carbonate 10 Gr (648 Mg) (antacid) Additional informationCallout TooltipWhat is the Proprietary Name?
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: Calcium Carbonate 10gr (648 Mg) Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
PH046
Score: 1

Code Structure
  • 0536 - Rugby Laboratories
    • 0536-1206 - Calcium Carbonate 10 Gr (648 Mg)

NDC 0536-1206-10

Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Calcium Carbonate 10 Gr (648 Mg) (antacid) with NDC 0536-1206 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Calcium Carbonate 10 Gr (648 Mg) (antacid) is calcium carbonate 10gr (648 mg). The product's dosage form is tablet and is administered via oral form.

Labeler Name: Rugby Laboratories

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
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.


Calcium Carbonate 10 Gr (648 Mg) (antacid) Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM CARBONATE 648 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACACIA (UNII: 5C5403N26O)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rugby Laboratories
Labeler Code: 0536
FDA Application Number: part331 Additional informationCallout TooltipWhat is the FDA Application Number?
This 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
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.

Start Marketing Date: 02-28-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Calcium Carbonate 10 Gr (648 Mg) (antacid) Product Label Images

Calcium Carbonate 10 Gr (648 Mg) (antacid) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

  • Relievesacid indigestionheartburnsour stomachupset stomach associated with these symptoms

Ask A Doctor Before Use If You Have

  • Kidney stonesa calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

Symptoms last more than 2 weeks.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Directions

  • Take one to four tablets dailydo not take more than 4 tablets in 24 hoursdo not use the maximum dosage for more than two weeks

Other Information

  • Each tablet contains: calcium 260 mgstore at room temperature

Inactive Ingredients

Acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Other

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSINGThis is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

* Please review the disclaimer below.

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