mesalamine

Generic: mesalamine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine .375 g/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-724
Product ID 46708-724_4ef59b85-e5a5-479f-a1fe-e1cee4d87670
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216967
Listing Expiration 2026-12-31
Marketing Start 2022-11-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708724
Hyphenated Format 46708-724

Supplemental Identifiers

RxCUI
825130
UPC
0346708724351
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 ANDA216967 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91)
source: ndc

Packages (2)

46708-724-35 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35) 46708-724-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91)

Ingredients (1)

mesalamine (.375 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": "4ef59b85-e5a5-479f-a1fe-e1cee4d87670", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0346708724351"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["4ef59b85-e5a5-479f-a1fe-e1cee4d87670"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35)", "package_ndc": "46708-724-35", "marketing_start_date": "20221103"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91)", "package_ndc": "46708-724-91", "marketing_start_date": "20221103"}], "brand_name": "MESALAMINE", "product_id": "46708-724_4ef59b85-e5a5-479f-a1fe-e1cee4d87670", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "46708-724", "generic_name": "MESALAMINE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MESALAMINE", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA216967", "marketing_category": "ANDA", "marketing_start_date": "20221103", "listing_expiration_date": "20261231"}