METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Generic: METFORMIN HYDROCHLORIDE

Labeler: Direct_Rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Generic Name METFORMIN HYDROCHLORIDE
Labeler Direct_Rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

METFORMIN HYDROCHLORIDE 500 mg/1

Identifiers & Regulatory

Product NDC 61919-450
Product ID 61919-450_49a00cee-36f5-b35c-e063-6394a90a4c0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201991
Listing Expiration 2027-12-31
Marketing Start 2017-02-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919450
Hyphenated Format 61919-450

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 EXTENDED RELEASE (source: ndc)
Generic Name METFORMIN HYDROCHLORIDE (source: ndc)
Application Number ANDA201991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-90)
source: ndc

Packages (2)

61919-450-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-30) 61919-450-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-90)

Ingredients (1)

METFORMIN HYDROCHLORIDE (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49a00cee-36f5-b35c-e063-6394a90a4c0b", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["4833deea-a19d-63b1-e054-00144ff8d46c"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-30)", "package_ndc": "61919-450-30", "marketing_start_date": "20170210"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-90)", "package_ndc": "61919-450-90", "marketing_start_date": "20190918"}], "brand_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "product_id": "61919-450_49a00cee-36f5-b35c-e063-6394a90a4c0b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "61919-450", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20170210", "listing_expiration_date": "20271231"}