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 1.2 g/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-711
Product ID 68382-711_d9ce9589-6aee-4dc3-a71b-f1c32ab9f552
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091640
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382711
Hyphenated Format 68382-711

Supplemental Identifiers

RxCUI
686429
UPC
0368382711199
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 ANDA091640 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19)
  • 34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)
source: ndc

Packages (2)

68382-711-19 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19) 68382-711-64 34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)

Ingredients (1)

mesalamine (1.2 g/1)

Linked Drug Pages (1)

mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d9ce9589-6aee-4dc3-a71b-f1c32ab9f552", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0368382711199"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["533bfaf5-0add-4b49-a4f2-ddea2b83f65d"], "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": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19)", "package_ndc": "68382-711-19", "marketing_start_date": "20170619"}, {"sample": false, "description": "34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)", "package_ndc": "68382-711-64", "marketing_start_date": "20170619"}], "brand_name": "mesalamine", "product_id": "68382-711_d9ce9589-6aee-4dc3-a71b-f1c32ab9f552", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "68382-711", "generic_name": "mesalamine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA091640", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}