atelvia

Generic: risedronate sodium

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atelvia
Generic Name risedronate sodium
Labeler allergan, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

risedronate sodium hemipentahydrate 30.1 mg/1, risedronate sodium monohydrate 4.9 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0430-0979
Product ID 0430-0979_5a50333a-4e4a-4ca3-806b-ee629efbaa7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022560
Listing Expiration 2027-12-31
Marketing Start 2010-12-01

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04300979
Hyphenated Format 0430-0979

Supplemental Identifiers

RxCUI
1020064 1020065 1020066
UNII
HU2YAQ274O F67L43UT5C

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 atelvia (source: ndc)
Generic Name risedronate sodium (source: ndc)
Application Number NDA022560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30.1 mg/1
  • 4.9 mg/1
source: ndc
Packaging
  • 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)
source: ndc

Packages (1)

0430-0979-03 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)

Ingredients (2)

risedronate sodium hemipentahydrate (30.1 mg/1) risedronate sodium monohydrate (4.9 mg/1)

Linked Drug Pages (1)

Atelvia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5a50333a-4e4a-4ca3-806b-ee629efbaa7a", "openfda": {"unii": ["HU2YAQ274O", "F67L43UT5C"], "rxcui": ["1020064", "1020065", "1020066"], "spl_set_id": ["c8b9ab88-1a26-46c3-80ec-4eaa45202021"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)", "package_ndc": "0430-0979-03", "marketing_start_date": "20101201"}], "brand_name": "Atelvia", "product_id": "0430-0979_5a50333a-4e4a-4ca3-806b-ee629efbaa7a", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Bisphosphonate [EPC]", "Bisphosphonate [EPC]", "Diphosphonates [CS]", "Diphosphonates [CS]"], "product_ndc": "0430-0979", "generic_name": "risedronate sodium", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atelvia", "active_ingredients": [{"name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE", "strength": "30.1 mg/1"}, {"name": "RISEDRONATE SODIUM MONOHYDRATE", "strength": "4.9 mg/1"}], "application_number": "NDA022560", "marketing_category": "NDA", "marketing_start_date": "20101201", "listing_expiration_date": "20271231"}