mesalamine

Generic: mesalamine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler bryant ranch prepack
Dosage Form KIT
Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8678
Product ID 63629-8678_6e83a681-f1fa-4b8e-827c-0d3fcf7ade93
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 636298678
Hyphenated Format 63629-8678

Supplemental Identifiers

RxCUI
238151

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
  • 4.0 g
  • 60 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (63629-8678-1) * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
source: ndc

Packages (1)

63629-8678-1 1 KIT in 1 CARTON (63629-8678-1) * 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": "6e83a681-f1fa-4b8e-827c-0d3fcf7ade93", "openfda": {"rxcui": ["238151"], "spl_set_id": ["9756d07b-2939-460f-94d3-e338c28cb993"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (63629-8678-1)  *  60 mL in 1 BOTTLE (45802-098-46)  *  1 SWAB in 1 PACKET", "package_ndc": "63629-8678-1", "marketing_start_date": "20090901"}], "brand_name": "Mesalamine", "product_id": "63629-8678_6e83a681-f1fa-4b8e-827c-0d3fcf7ade93", "dosage_form": "KIT", "product_ndc": "63629-8678", "generic_name": "Mesalamine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "application_number": "ANDA076751", "marketing_category": "ANDA", "marketing_start_date": "20090901", "listing_expiration_date": "20261231"}