glipizide

Generic: glipizide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glipizide
Generic Name glipizide
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

glipizide 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-281
Product ID 64980-281_efa05b41-c609-4076-adf4-75071cd5f5f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204720
Listing Expiration 2027-12-31
Marketing Start 2017-04-24

Pharmacologic Class

Established (EPC)
sulfonylurea [epc]
Chemical Structure
sulfonylurea compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980281
Hyphenated Format 64980-281

Supplemental Identifiers

RxCUI
310489 314006 315107
UPC
0364980279031 0364980281010 0364980280013
UNII
X7WDT95N5C
NUI
N0000175608 M0020795

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 glipizide (source: ndc)
Generic Name glipizide (source: ndc)
Application Number ANDA204720 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-05)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-10)
source: ndc

Packages (3)

64980-281-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-01) 64980-281-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-05) 64980-281-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-10)

Ingredients (1)

glipizide (10 mg/1)

Linked Drug Pages (1)

Glipizide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "efa05b41-c609-4076-adf4-75071cd5f5f0", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0364980279031", "0364980281010", "0364980280013"], "unii": ["X7WDT95N5C"], "rxcui": ["310489", "314006", "315107"], "spl_set_id": ["0ffe361a-c99b-4f68-a7e2-a67a71c0c496"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-01)", "package_ndc": "64980-281-01", "marketing_start_date": "20170424"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-05)", "package_ndc": "64980-281-05", "marketing_start_date": "20170424"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-281-10)", "package_ndc": "64980-281-10", "marketing_start_date": "20170424"}], "brand_name": "Glipizide", "product_id": "64980-281_efa05b41-c609-4076-adf4-75071cd5f5f0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "64980-281", "generic_name": "Glipizide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "10 mg/1"}], "application_number": "ANDA204720", "marketing_category": "ANDA", "marketing_start_date": "20170424", "listing_expiration_date": "20271231"}