glipizide

Generic: glipizide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glipizide
Generic Name glipizide
Labeler zydus lifesciences limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

glipizide 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1099
Product ID 70771-1099_91352956-7b71-40ff-9a1f-b8bf4fe03763
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203499
Listing Expiration 2027-12-31
Marketing Start 2018-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711099
Hyphenated Format 70771-1099

Supplemental Identifiers

RxCUI
310489 314006 315107
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 ANDA203499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-0)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1099-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1099-2)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-5)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-6)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-9)
source: ndc

Packages (7)

70771-1099-0 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-0) 70771-1099-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-1) 70771-1099-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-3) 70771-1099-4 10 BLISTER PACK in 1 CARTON (70771-1099-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1099-2) 70771-1099-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-5) 70771-1099-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-6) 70771-1099-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-9)

Ingredients (1)

glipizide (5 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": "91352956-7b71-40ff-9a1f-b8bf4fe03763", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["X7WDT95N5C"], "rxcui": ["310489", "314006", "315107"], "spl_set_id": ["ff98778f-7c76-4f41-8c6a-d335c74b3a1f"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-0)", "package_ndc": "70771-1099-0", "marketing_start_date": "20180725"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-1)", "package_ndc": "70771-1099-1", "marketing_start_date": "20180725"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-3)", "package_ndc": "70771-1099-3", "marketing_start_date": "20180725"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1099-4)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1099-2)", "package_ndc": "70771-1099-4", "marketing_start_date": "20180725"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-5)", "package_ndc": "70771-1099-5", "marketing_start_date": "20180725"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-6)", "package_ndc": "70771-1099-6", "marketing_start_date": "20180725"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1099-9)", "package_ndc": "70771-1099-9", "marketing_start_date": "20180725"}], "brand_name": "Glipizide", "product_id": "70771-1099_91352956-7b71-40ff-9a1f-b8bf4fe03763", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70771-1099", "generic_name": "Glipizide", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glipizide", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "5 mg/1"}], "application_number": "ANDA203499", "marketing_category": "ANDA", "marketing_start_date": "20180725", "listing_expiration_date": "20271231"}