mesalamine

Generic: mesalamine

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler padagis israel pharmaceuticals ltd
Dosage Form KIT
Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-923
Product ID 45802-923_9e3de2df-02db-474c-9e16-47aeea34b2c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076751
Listing Expiration 2026-12-31
Marketing Start 2009-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802923
Hyphenated Format 45802-923

Supplemental Identifiers

RxCUI
238151

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 ANDA076751 (source: ndc)

Resolved Composition

Strengths
  • 4 g/60 ml
  • 4 g
  • 60 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (45802-923-41) * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
source: ndc

Packages (1)

45802-923-41 1 KIT in 1 CARTON (45802-923-41) * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "9e3de2df-02db-474c-9e16-47aeea34b2c5", "openfda": {"rxcui": ["238151"], "spl_set_id": ["d50f2c37-5675-49f3-bdd4-3b16d333ed40"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (45802-923-41)  *  60 mL in 1 BOTTLE (45802-098-46)  *  1 SWAB in 1 PACKET", "package_ndc": "45802-923-41", "marketing_start_date": "20090901"}], "brand_name": "Mesalamine", "product_id": "45802-923_9e3de2df-02db-474c-9e16-47aeea34b2c5", "dosage_form": "KIT", "product_ndc": "45802-923", "generic_name": "Mesalamine", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "application_number": "ANDA076751", "marketing_category": "ANDA", "marketing_start_date": "20090901", "listing_expiration_date": "20261231"}