fosamax plus d

Generic: alendronate sodium and cholecalciferol

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosamax plus d
Generic Name alendronate sodium and cholecalciferol
Labeler organon llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/1, cholecalciferol 5600 [iU]/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-136
Product ID 78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021762
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
vitamin d [epc]
Chemical Structure
vitamin d [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206136
Hyphenated Format 78206-136

Supplemental Identifiers

RxCUI
904462 904465 904492 904495
UNII
2UY4M2U3RA 1C6V77QF41
NUI
M0022797 N0000175952

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 fosamax plus d (source: ndc)
Generic Name alendronate sodium and cholecalciferol (source: ndc)
Application Number NDA021762 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/1
  • 5600 [iU]/1
source: ndc
Packaging
  • 4 TABLET in 1 BLISTER PACK (78206-136-01)
source: ndc

Packages (1)

78206-136-01 4 TABLET in 1 BLISTER PACK (78206-136-01)

Ingredients (2)

alendronate sodium (70 mg/1) cholecalciferol (5600 [iU]/1)

Linked Drug Pages (1)

FOSAMAX PLUS D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10aeb309-f6e1-49c6-ac6f-ad743db28527", "openfda": {"nui": ["M0022797", "N0000175952"], "unii": ["2UY4M2U3RA", "1C6V77QF41"], "rxcui": ["904462", "904465", "904492", "904495"], "spl_set_id": ["10307e7e-9a84-4aa1-8c5c-4b209cffe4d1"], "pharm_class_cs": ["Vitamin D [CS]"], "pharm_class_epc": ["Vitamin D [EPC]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BLISTER PACK (78206-136-01)", "package_ndc": "78206-136-01", "marketing_start_date": "20210601"}], "brand_name": "FOSAMAX PLUS D", "product_id": "78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]", "Vitamin D [CS]", "Vitamin D [EPC]"], "product_ndc": "78206-136", "generic_name": "ALENDRONATE SODIUM and CHOLECALCIFEROL", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FOSAMAX PLUS D", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/1"}, {"name": "CHOLECALCIFEROL", "strength": "5600 [iU]/1"}], "application_number": "NDA021762", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}