NDC 63044-153 Inatal Advance

NDC Product Code 63044-153

NDC CODE: 63044-153

Proprietary Name: Inatal Advance What 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.

Product Characteristics

Color(s):
WHITE (C48325 - DYE-FREE)
Shape: OVAL (C48345)
Size(s):
5 MM
Imprint(s):
CPC2859
Score: 2

NDC Code Structure

NDC 63044-153-01

Package Description: 90 TABLET, COATED in 1 BOTTLE

NDC 63044-153-64

Package Description: 9 BLISTER PACK in 1 BOX, UNIT-DOSE > 10 TABLET, COATED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Inatal Advance with NDC 63044-153 is a product labeled by Nnodum Pharmaceuticals. The product's dosage form is and is administered via form.

Inactive Ingredient(s)

About 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nnodum Pharmaceuticals
Labeler Code: 63044
Start Marketing Date: 06-10-2005 What 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: 12-31-2018 What 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: I - INACTIVATED, the listing data was inactivated by the FDA. What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Inatal Advance 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

Description

INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron.Each tablet contains:Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U.Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mgCalcium (as calcium carbonate) . . . . . . . . . . 200 mgElemental Iron (as carbonyl iron) . . . . . . . . . . 90 mgVitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U.Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U.Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mgVitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mgNiacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mgVitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mgFolic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mgVitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcgZinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mgCopper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mgMagnesium (as magnesium oxide, USP) . . . . . 30 mgDocusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mgINACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide

Indications:

INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.

Precautions:

Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually staring at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dosage And Administration:

One tablet daily or as directed by a physician.

How Supplied:

NDC 63044-153-64 Unit Dose Packs of 90’s with each blister card containing 10 tablets per card.Store at controlled room temperature 15°- 30°C (59°-86°F).KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Manufactured For Nnodum PharmaceuticalsCincinnati, Ohio 45229

* Please review the disclaimer below.