mesalamine

Generic: mesalamine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler rising pharma holdings, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

mesalamine 1000 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-246
Product ID 16571-246_92e26463-9c71-456e-b800-351162846b68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219028
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571246
Hyphenated Format 16571-246

Supplemental Identifiers

RxCUI
248420
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 ANDA219028 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)
  • 12 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)
source: ndc

Packages (2)

16571-246-03 5 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16) 16571-246-72 12 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)

Ingredients (1)

mesalamine (1000 mg/1)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "92e26463-9c71-456e-b800-351162846b68", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["248420"], "spl_set_id": ["c26ae6cb-041b-4cfc-90ca-c4e1cb23458c"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (16571-246-03)  / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)", "package_ndc": "16571-246-03", "marketing_start_date": "20250414"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (16571-246-72)  / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)", "package_ndc": "16571-246-72", "marketing_start_date": "20250414"}], "brand_name": "Mesalamine", "product_id": "16571-246_92e26463-9c71-456e-b800-351162846b68", "dosage_form": "SUPPOSITORY", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "16571-246", "generic_name": "Mesalamine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1000 mg/1"}], "application_number": "ANDA219028", "marketing_category": "ANDA", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}