mesalamine

Generic: mesalamine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 800 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-435
Product ID 68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203286
Listing Expiration 2026-12-31
Marketing Start 2018-08-02

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382435
Hyphenated Format 68382-435

Supplemental Identifiers

RxCUI
833234
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mesalamine (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA203286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
  • 10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)
source: ndc

Packages (2)

68382-435-28 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28) 68382-435-77 10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)

Ingredients (1)

mesalamine (800 mg/1)

Linked Drug Pages (1)

mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2b40002-6c58-4c89-b178-c915a59cb2dd", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["833234"], "spl_set_id": ["ad8c7930-92e2-4372-a874-da22b9ae333e"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)", "package_ndc": "68382-435-28", "marketing_start_date": "20180802"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-435-77)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)", "package_ndc": "68382-435-77", "marketing_start_date": "20180802"}], "brand_name": "mesalamine", "product_id": "68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "68382-435", "generic_name": "mesalamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "800 mg/1"}], "application_number": "ANDA203286", "marketing_category": "ANDA", "marketing_start_date": "20180802", "listing_expiration_date": "20261231"}