Sucralfate
NDC 29033-003
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Sucralfate is a ANDA-approved product labeled by Nostrum Laboratories, Inc.. This medication is used to treat and prevent ulcers in the intestines. It is supplied as a white product. This product entry covers the primary NDC 29033-003 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
29033-003
Proprietary Name:
Sucralfate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
29033
Product Label ID:
FDA Application Number: [6]
ANDA074415
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-17-2020
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325 - WHITE)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
NS;1
Score:
2
Code Structure Chart
Product Details
What is NDC 29033-003?
The NDC code 29033-003 is assigned by the FDA to the product Sucralfate. This pharmaceutical product is labeled by Nostrum Laboratories, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 29033-003-01, 29033-003-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to treat and prevent ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SUCRALFATE (UNII: XX73205DH5)
- SUCRALFATE (UNII: XX73205DH5) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- POVIDONE (UNII: FZ989GH94E)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 314234 - sucralfate 1 GM Oral Tablet
- RxCUI: 314234 - sucralfate 1000 MG Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Acetazolamide
Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Acetazolamide decreases the pressure in the eye. Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain) sickness. Acetazolamide is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]
Sucralfate
Sucralfate is used to treat and prevent the return of duodenal ulcers (ulcers located in first part of the small intestine). Treatment with other medications, such as antibiotics, may also be necessary to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) Sucralfate is in a class of medications called protectants. It sticks to damaged ulcer tissue and protects against acid and enzymes so healing can occur.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What 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.
What 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
