glucotrol xl

Generic: glipizide

Labeler: roerig
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glucotrol xl
Generic Name glipizide
Labeler roerig
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

glipizide 10 mg/1

Manufacturer
Roerig

Identifiers & Regulatory

Product NDC 0049-0178
Product ID 0049-0178_ce46d6b5-eab4-4630-8480-f13885be938e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020329
Listing Expiration 2026-12-31
Marketing Start 2013-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00490178
Hyphenated Format 0049-0178

Supplemental Identifiers

RxCUI
310489 314006 315107 865568 865571 865573
UPC
0300490174022 0300490170017
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 glucotrol xl (source: ndc)
Generic Name glipizide (source: ndc)
Application Number NDA020329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-08)
source: ndc

Packages (1)

0049-0178-08 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-08)

Ingredients (1)

glipizide (10 mg/1)

Linked Drug Pages (1)

Glucotrol XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ce46d6b5-eab4-4630-8480-f13885be938e", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0300490174022", "0300490170017"], "unii": ["X7WDT95N5C"], "rxcui": ["310489", "314006", "315107", "865568", "865571", "865573"], "spl_set_id": ["eed99b60-d043-4249-9b2a-f05e46fb588d"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Roerig"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-08)", "package_ndc": "0049-0178-08", "marketing_start_date": "20130509"}], "brand_name": "Glucotrol XL", "product_id": "0049-0178_ce46d6b5-eab4-4630-8480-f13885be938e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "0049-0178", "generic_name": "glipizide", "labeler_name": "Roerig", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glucotrol", "brand_name_suffix": "XL", "active_ingredients": [{"name": "GLIPIZIDE", "strength": "10 mg/1"}], "application_number": "NDA020329", "marketing_category": "NDA", "marketing_start_date": "20130509", "listing_expiration_date": "20261231"}