metformin hydrochloride

Generic: metformin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-987
Product ID 43353-987_4900492c-70fa-e5b5-e063-6294a90af743
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2027-12-31
Marketing Start 2013-09-11

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353987
Hyphenated Format 43353-987

Supplemental Identifiers

RxCUI
861004 861007 861010
UNII
786Z46389E

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 metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43353-987-30)
  • 600 TABLET in 1 BOTTLE (43353-987-31)
  • 1300 TABLET in 1 BOTTLE (43353-987-43)
  • 45 TABLET in 1 BOTTLE (43353-987-45)
  • 60 TABLET in 1 BOTTLE (43353-987-53)
  • 90 TABLET in 1 BOTTLE (43353-987-60)
  • 135 TABLET in 1 BOTTLE (43353-987-73)
  • 180 TABLET in 1 BOTTLE (43353-987-80)
  • 225 TABLET in 1 BOTTLE (43353-987-86)
  • 2400 TABLET in 1 BOTTLE (43353-987-87)
  • 450 TABLET in 1 BOTTLE (43353-987-96)
source: ndc

Packages (11)

43353-987-30 30 TABLET in 1 BOTTLE (43353-987-30) 43353-987-31 600 TABLET in 1 BOTTLE (43353-987-31) 43353-987-43 1300 TABLET in 1 BOTTLE (43353-987-43) 43353-987-45 45 TABLET in 1 BOTTLE (43353-987-45) 43353-987-53 60 TABLET in 1 BOTTLE (43353-987-53) 43353-987-60 90 TABLET in 1 BOTTLE (43353-987-60) 43353-987-73 135 TABLET in 1 BOTTLE (43353-987-73) 43353-987-80 180 TABLET in 1 BOTTLE (43353-987-80) 43353-987-86 225 TABLET in 1 BOTTLE (43353-987-86) 43353-987-87 2400 TABLET in 1 BOTTLE (43353-987-87) 43353-987-96 450 TABLET in 1 BOTTLE (43353-987-96)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4900492c-70fa-e5b5-e063-6294a90af743", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["273d86b0-9d30-48c9-8918-c5e1ececa951"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-987-30)", "package_ndc": "43353-987-30", "marketing_start_date": "20141222"}, {"sample": false, "description": "600 TABLET in 1 BOTTLE (43353-987-31)", "package_ndc": "43353-987-31", "marketing_start_date": "20240610"}, {"sample": false, "description": "1300 TABLET in 1 BOTTLE (43353-987-43)", "package_ndc": "43353-987-43", "marketing_start_date": "20240610"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-987-45)", "package_ndc": "43353-987-45", "marketing_start_date": "20150105"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-987-53)", "package_ndc": "43353-987-53", "marketing_start_date": "20150224"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-987-60)", "package_ndc": "43353-987-60", "marketing_start_date": "20150202"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (43353-987-73)", "package_ndc": "43353-987-73", "marketing_start_date": "20141221"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-987-80)", "package_ndc": "43353-987-80", "marketing_start_date": "20160202"}, {"sample": false, "description": "225 TABLET in 1 BOTTLE (43353-987-86)", "package_ndc": "43353-987-86", "marketing_start_date": "20141222"}, {"sample": false, "description": "2400 TABLET in 1 BOTTLE (43353-987-87)", "package_ndc": "43353-987-87", "marketing_start_date": "20240610"}, {"sample": false, "description": "450 TABLET in 1 BOTTLE (43353-987-96)", "package_ndc": "43353-987-96", "marketing_start_date": "20200513"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "43353-987_4900492c-70fa-e5b5-e063-6294a90af743", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "43353-987", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20130911", "listing_expiration_date": "20271231"}