Mesalamine with NDC 70771-1625 is a a human prescription drug product labeled by Cadila Healthcare Limited. The generic name of Mesalamine is mesalamine. The product's dosage form is capsule, extended release and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 825130.
Dosage Form: Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Product Type: Human Prescription Drug What 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.
Mesalamine Active Ingredient(s) What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
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.
- ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
- HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
- TALC (UNII: 7SEV7J4R1U)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- GELATIN (UNII: 2G86QN327L)
- WATER (UNII: 059QF0KO0R)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- SUCROSE (UNII: C151H8M554)
- STARCH, CORN (UNII: O8232NY3SJ)
Administration Route(s) What 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.
Pharmacological Class(es) What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
- Aminosalicylate - [EPC] (Established Pharmacologic Class)
- Aminosalicylic Acids - [CS]
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Cadila Healthcare Limited
Labeler Code: 70771
FDA Application Number: ANDA208954 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.
Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
Start Marketing Date: 08-13-2021 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: 12-31-2022 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: N - NO 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.